1. TEL AVIV, Israel and RALEIGH, NC, Feb. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced its plans to expand the Company's global Phase 2/3 study of opaganib[1] in patients with severe COVID-19 to the U.S., following U.S. Food and Drug Administration (FDA) review of the data from the U.S. Phase 2 study of opaganib and receipt of its recommendations.  

    RedHill Biopharma Logo

    Expansion of the global Phase 2/3 study to the U.S. will entail adjustments to the protocol based on the FDA's recommendations and ongoing discussions. The expansion of the study to the U.S. will help further speed-up enrollment, expanding the study to a total of 8 countries and approximately 40 recruiting…

    TEL AVIV, Israel and RALEIGH, NC, Feb. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced its plans to expand the Company's global Phase 2/3 study of opaganib[1] in patients with severe COVID-19 to the U.S., following U.S. Food and Drug Administration (FDA) review of the data from the U.S. Phase 2 study of opaganib and receipt of its recommendations.  

    RedHill Biopharma Logo

    Expansion of the global Phase 2/3 study to the U.S. will entail adjustments to the protocol based on the FDA's recommendations and ongoing discussions. The expansion of the study to the U.S. will help further speed-up enrollment, expanding the study to a total of 8 countries and approximately 40 recruiting sites, with additional sites and countries being added. The 464-patient study is over 50% enrolled and is expected to deliver top-line data in the second quarter of 2021.

    The global Phase 2/3 study recently underwent a positive DSMB futility review, which is suggestive that the study has the potential for a positive outcome. RedHill recently announced positive top-line safety and efficacy data from the non-powered U.S. Phase 2 study with opaganib in patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14 across key primary and secondary efficacy outcomes. The Phase 2 data also showed no material safety differences between the opaganib and placebo treatment arms - further adding to the growing safety database for opaganib.

    Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity, that targets a human cell component involved in viral replication and is therefore expected to be effective against emerging viral variants with mutations in the spike protein.

    About Opaganib (Yeliva®, ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a U.S. Phase 2 study.

    Preclinical data have demonstrated anti-inflammatory, antiviral and anti-thrombotic activities of opaganib, with the potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Opaganib also demonstrated reduced blood clot length, weight and total thrombus score in a preclinical model of Acquired Respiratory Distress Syndrome. Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         



    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and includes statements regarding the timing of the reporting of a full analysis of the data from the U.S. Phase 2 trial evaluating opaganib, the timing of potential emergency use applications for opaganib and the timing of reporting of top-line data for the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's COVID-19 Phase 2/3 study evaluating opaganib will not be successful; the risk of a delay in receiving top-line data from the Phase 2/3 study and in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that data received from the Phase 2/3 study, even if successful, will not be sufficient to support filing or approval of emergency use applications or other marketing applications in certain or all geographical regions; the risk that the full analysis of data from the U.S. Phase 2 clinical study evaluating opaganib will be delayed or will differ from the preliminary data; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment will be delayed; the risk that the Phase 2/3 study will not provide a clear picture of opaganib's potential in treating severe COVID-19; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of severe COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    References:

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [3] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [4] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [5] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

     

    Company contact:

    Media contacts:

    Adi Frish

    U.S.: Bryan Gibbs, Finn Partners

    Chief Corporate & Business Development Officer

    +1 212 529 2236

    RedHill Biopharma

    +972-54-6543-112

    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783



     

     

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    SOURCE RedHill Biopharma Ltd.

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  2. TEL AVIV, Israel and RALEIGH, N.C., Feb. 18, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced agreements with Cosmo Pharmaceuticals NV (SIX: COPN) ("Cosmo") to manufacture two key products; RedHill's largest selling product in the U.S., Movantik®, and RHB-204, currently in a Phase 3 U.S. study as a stand-alone, first-line orally-administered treatment for pulmonary nontuberculous mycobacteria (NTM) disease.

    RedHill Biopharma Logo

    "Movantik is currently our biggest commercial product. This agreement strengthens our qualified supply base and capacity moving forward and solidifies our ongoing strategic relationship with Cosmo," said Steven Thomasian, RedHill's Vice President

    TEL AVIV, Israel and RALEIGH, N.C., Feb. 18, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced agreements with Cosmo Pharmaceuticals NV (SIX: COPN) ("Cosmo") to manufacture two key products; RedHill's largest selling product in the U.S., Movantik®, and RHB-204, currently in a Phase 3 U.S. study as a stand-alone, first-line orally-administered treatment for pulmonary nontuberculous mycobacteria (NTM) disease.

    RedHill Biopharma Logo

    "Movantik is currently our biggest commercial product. This agreement strengthens our qualified supply base and capacity moving forward and solidifies our ongoing strategic relationship with Cosmo," said Steven Thomasian, RedHill's Vice President of Supply Chain Management.

    "We are happy to strengthen our partnership with RedHill with the manufacturing of these two important products and therefore to further expand Cosmo's production capacities and capabilities," said Davide Malavasi, Cosmo's Head of Manufacturing.

    Movantik is the leading prescribed oral peripherally acting mu-opioid receptor antagonist (PAMORA) in the U.S. specifically designed to treat opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain[1]. OIC is the most common and debilitating gastrointestinal adverse effect associated with opioid therapy, estimated to affect between 40-80% of the millions of patients taking chronic opioid therapy each year[2].

    RHB-204 is an investigational proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed as a stand-alone first-line treatment for pulmonary NTM disease caused by Mycobacterium avium Complex (MAC). Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world[3]. There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 2017, with U.S. market potential estimated at over $500 million[4]. RHB-204 has received FDA Fast Track, Orphan Drug and QIDP designations aimed at accelerating development and FDA review and extending U.S. market exclusivity to a potential total of 12 years, to be granted at the time of FDA approval.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[5], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[6], and Aemcolo® for the treatment of travelers' diarrhea in adults[7]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    About Cosmo Pharmaceuticals

    Cosmo is a specialty pharmaceutical company focused on developing and commercializing products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius™ its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo® to RedHill Biopharma for the US and has licensed Relafalk® to Dr. Falk Gmbh for the EU and other countries. For additional information on Cosmo and its products please visit the Company's website: www.cosmopharma.com

    Important Safety Information About Movantik

    Movantik® (naloxegol) is contraindicated in:

    • Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.
    • Patients receiving strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.
    • Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.

    Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patient (eg, multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.

    Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5 mg once daily.

    Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Post marketing cases of GI perforation, including fatal cases, were reported when Movantik was used in patients at risk of GI perforation (eg, infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.

    The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).

    Movantik® (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dosage escalation.

    Click here for the Medication Guide and full Prescribing Information for Movantik.

    You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties, including without limitation, the risk that the agreement with Cosmo will not provide high-quality manufacturing capacity for Movantik® and RHB-204 or be sufficient to meet market demands, as well as other risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236



     

    [1] Since Jan 2017. IQVIA NPA

    [2] Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.

    [3] Henkle E, et al. Population-based Incidence of Pulmonary Nontuberculous Mycobacterial Disease in Oregon 2007 to 2012 Annals of the American Thoracic Society. 2015; 12(5):642-7.

    [4] Foster|Rosenblatt, 2017.

    [5] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [6] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [7] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  3. TEL AVIV, Israel and RALEIGH, N.C., Feb. 17, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the first patient was dosed in its U.S. Phase 2/3 study of orally-administered RHB-107 (upamostat)[1], an investigational new drug for patients with symptomatic COVID-19 who do not require hospital care.

    Dror Ben-Asher, RedHill's CEO said: "RedHill is rapidly advancing two Phase 3-stage, orally-administered, novel molecules for the treatment of COVID-19: RHB-107 for outpatient use and opaganib for hospitalized patients. With these two promising and complementary shots on goal across the disease severity spectrum, RedHill is positioned at the very forefront of COVID-19 therapeutic research, aiming to address both existing and emerging mutations."

    The U.S. Phase 2/3 study (NCT04723527) is aimed at evaluating treatment with RHB-107 in patients with symptomatic COVID-19 early in the course of the disease, with a simple once-daily oral treatment in an outpatient setting.

    RHB-107 is a novel, potent inhibitor of serine proteases, that targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model and previous preclinical work demonstrated potential tissue-protective action. Previous clinical studies of RHB-107 included several Phase 1 and Phase 2 studies in different indications, demonstrating its clinical safety profile in approximately 200 patients.

    "Dosing of the first patient in the Phase 2/3 study of RHB-107 in patients with symptoms but not needing hospital care, the largest COVID-19 patient group, is a key step forward in RedHill's efforts to help combat the widespread effects of this pandemic. Together with opaganib, we now have two novel, orally-administered compounds, with unique mechanisms of action, in advanced development for treating patients at different stages of COVID-19 disease," said Terry F. Plasse MD, Medical Director at RedHill. "The ability to treat patients early in the course of COVID-19 disease, with an oral therapy designed to be used outside the hospital, and with a compound expected to be effective against emerging viral variants, has the potential to be a game-changer in managing this disease. The ground-breaking design of the study allows us to collect data at a level previously possible only in hospital while enabling patients to stay in the comfort of their homes and decreasing exposure risk of this highly contagious disease."

    This study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107. The first part of the study is designed for dose selection and is planned to enroll 60 patients. The second part of the study is planned to enroll 250 patients and will evaluate time to sustained recovery from illness as the primary endpoint. Each patient will be tested for specific viral strain.

    The study is unique in a COVID-19 trial setting in its extensive use of telemetry and electronic patient-reported outcome (ePRO) data collection and is based on the latest FDA guidance for symptom monitoring. Following the patients' initial visit to a medical facility, a research-trained nurse will make periodic home visits to study patients to collect samples for safety and virology monitoring. This innovative use of home-based safety and efficacy monitoring technologies, together with home nursing support, enables patients to participate in the study from home with the benefit of hospital-level monitoring, enhancing patient comfort and markedly decreasing the risk of SARS-CoV-2 exposure to medical staff and other members of the public.

    In parallel, the late-stage development program for RedHill's second COVID-19 drug candidate, opaganib[2] in patients hospitalized with severe COVID-19, is progressing rapidly. Recently announced top-line results from the U.S. Phase 2 study of opaganib demonstrated safety and positive efficacy data across key primary and secondary endpoints. The global Phase 2/3 study continues to enroll, having recently received a positive DSMB futility review, with top-line data and potential subsequent global emergency use authorization applications expected in the second quarter of 2021.

    About RHB-107 (upamostat)

    RHB-107 is a proprietary, first-in-class, orally-administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects. RHB-107 targets human cell factors involved in preparing the spike protein for viral entry into target cells and is therefore expected to be effective against emerging viral variants with mutations in the spike protein. RHB-107 is being evaluated in a U.S. Phase 2/3 study for treatment of patients with symptomatic COVID-19 who do not require inpatient care. In addition, RHB-107 has potential in targeting cancer, inflammatory lung diseases and gastrointestinal diseases. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (FSE: HPHA) (formerly WILEX AG) for all indications.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that enrollment in the Company's Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, not completed or not successful; the risk that RHB-107 will not be effective against emerging viral variants with mutations in the spike protein; the risk that the Company's Phase 2/3 development program evaluating opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all;; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment will be delayed; the risk that other COVID-19 patients treated with RHB-107 or opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of RHB-107 and opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    1. RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution in the United States.

    2. Opaganib (Yeliva®, ABC294640) is an investigational new drug, not available for commercial distribution in the United States.

    3. Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    4. Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com

    5. Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contacts:

    U.S.: Bryan Gibbs, Finn Partners

    +1 212 529 2236



    UK: Amber Fennell, Consilium

    +44 (0) 7739 658 783 

     

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  4. TEL AVIV, Israel and RALEIGH, N.C., Feb. 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in February:

    SVB Leerink 10th Annual Global Healthcare Conference (Feb 22-26, 2021)

    Presentation and Q&A: Thursday, February 25, 8:40 am ET  

    Speaker: Dror Ben-Asher, Chief Executive Officer

    BIO CEO & Investor Digital Conference (Feb 16-18, 2021)

    Presentation: Available on-demand from February 16

    Speaker: Guy Goldberg, Chief Business Officer

    The webcasts will be available for 30 days on the Company's website: https://ir.redhillbio.com.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

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    SOURCE RedHill Biopharma Ltd.

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  5. TEL AVIV, Israel and RALEIGH, N.C., Jan. 29, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of opaganib[1] in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and safety data from the first 175 patients.

     

    RedHill Biopharma Logo

     

    "Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. The positive and unanimous DSMB recommendation is a significant…

    TEL AVIV, Israel and RALEIGH, N.C., Jan. 29, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the global Phase 2/3 study of opaganib[1] in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and safety data from the first 175 patients.

     

    RedHill Biopharma Logo

     

    "Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. The positive and unanimous DSMB recommendation is a significant milestone in the progress of our development program for COVID-19 disease. Taken together with the positive results from the Phase 2 study, this unanimous DSMB recommendation to continue the global Phase 2/3 study suggests we are heading in the right direction from both a safety and efficacy perspective," said Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill. "This is a particularly difficult time in the fight against the pandemic, with viral mutations increasing infection rates and impacting many aspects of society's response to the pandemic. The need for effective therapeutics is clear. Opaganib's mechanism of action targets the human host cell component SK2, which is involved in both viral replication inside the cell and downstream inflammatory/immune responses. This means that opaganib is expected to maintain its activity irrespective of the worrisome mutations in SARS-CoV-2 spike protein. These mutations underscore the potential of SARS-CoV-2 to develop resistance to direct anti-viral mAbs, and to potentially impact vaccine effectiveness. This is an important advantage of opaganib in the face of the growing multitude of viral strains and provides the promise of a much-needed treatment option to help get patients off oxygen and out of hospital."

    This positive DSMB futility review, which is suggestive that the global Phase 2/3 study is progressing as expected, adds to positive top-line safety and efficacy data from the U.S. Phase 2 study, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14 across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale. The Phase 2 data also showed no material safety differences between the opaganib and placebo treatment arms - further adding to the growing safety database for opaganib. Full analysis of the Phase 2 data, including viral and inflammatory biomarker analyses, baseline risk factors and standard-of-care background therapy stratification, is expected in the coming weeks and is planned to be provided for peer review.

    In-line with rapidly evolving clinical practice and guidelines for treatment of hospitalized COVID-19 patients, which aim to minimize patient intubation and mechanical ventilation, the primary endpoint of the global Phase 2/3 study is now the proportion of patients reaching room air (no longer requiring oxygen supplementation) by Day 14, previously a key secondary endpoint. Intubation and mechanical ventilation remains as a secondary endpoint. Correspondingly, a blind resizing of the study is planned, to approximately 460 patients. There are approximately 30 study sites in 7 countries with additional sites and countries being added in the coming days and weeks. Top-line data, and potential global emergency use authorization applications are expected in the second quarter of 2021.

    About Opaganib (Yeliva®, ABC294640)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a U.S. Phase 2 study.

    Preclinical data have demonstrated anti-inflammatory, antiviral and anti-thrombotic activities of opaganib, with the potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Opaganib also demonstrated reduced blood clot length, weight and total thrombus score in a preclinical model of Acquired Respiratory Distress Syndrome. Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and includes statements regarding the timing of the reporting of a full analysis of the data from the U.S. Phase 2 trial evaluating opaganib, the timing of potential emergency use applications for opaganib and the timing of reporting of top-line data for the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be successful; the risk of a delay in receiving top-line data from the Phase 2/3 study and in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the full analysis of data from the U.S. Phase 2 clinical study evaluating opaganib will be delayed or will differ from the preliminary data; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [3] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [4] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [5] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  6. TEL AVIV, Israel and RALEIGH, N.C., Jan. 28, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ("Cosmo") to further expand manufacturing capacity for opaganib (Yeliva®, ABC294640)[1], to address prospective demand subsequent to potential global emergency use authorizations.

    "The growing concerns over viral mutations and the spread of new potent and evasive viral strains have increased the dire need for new COVID-19 therapeutics," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "We are very pleased to expand the manufacturing capacity of opaganib with a partner of Cosmo's quality. Opaganib is designed to act broadly against different viral strains irrespective of mutations in the Spike protein. Opaganib is a Phase 2/3-stage novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. By targeting SK2, a human cell component involved in viral replication irrespective of mutations in the viral Spike protein, opaganib potentially addresses the emergence of new strains."  

    "We are delighted to further strengthen our partnership with RedHill on expanded opaganib manufacturing, and to play a part in trying to help alleviate the suffering the coronavirus pandemic is causing across the world, should opaganib be approved for use," said Davide Malavasi, Cosmo's Head of Manufacturing.

    The global Phase 2/3 study of opaganib in severe COVID-19 pneumonia (NCT04467840) is ongoing, with patients enrolled in more than 30 sites in multiple countries. An interim independent Data and Safety Monitoring Board (DSMB) futility analysis will be conducted in the coming days, evaluating data from the first 135 subjects that have reached the primary endpoint. The study has previously undergone two unblinded independent DSMB safety data reviews, with unanimous recommendations to continue the study.

    Preliminary data from a non-powered U.S. Phase 2 study of 40 hospitalized patients recently showed that opaganib was safe and demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14 across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a U.S. Phase 2 study.

    Preclinical data have demonstrated anti-inflammatory, antiviral and anti-thrombotic activities of opaganib, with the potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Opaganib also demonstrated reduced blood clot length, weight and total thrombus score in a preclinical model of Acquired Respiratory Distress Syndrome. Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.  

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[2], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[3], and Aemcolo® for the treatment of travelers' diarrhea in adults[4]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    About Cosmo Pharmaceuticals

    Cosmo is a specialty pharmaceutical company focused on developing and commercializing products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo® to RedHill Biopharma for the US and has licensed Relafalk® to Dr. Falk Gmbh for the EU and other countries. For additional information on Cosmo and its products please visit the Company's website: www.cosmopharma.com

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties, including without limitation, the risk that the agreement with Cosmo will not provide high-quality manufacturing capacity for opaganib or be sufficient to meet market demands; the risk that opaganib will not address resistance due to viral mutations; the risk of delay in reporting top-line data from the global Phase 2/3 study of opaganib in severe COVID-19 pneumonia and the timing of global emergency us applications if at all; as well as other risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the risk that the Company will not succeed to complete the patient recruitment of the global Phase 2/3 study; the risk that the global Phase 2/3 clinical study evaluating opaganib will not be successful or, if successful, will not suffice for emergency use applications or regulatory marketing approval without the need for additional clinical and/or other studies; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [3] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com .  

    [4] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com .      

    [5] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

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  7. TEL AVIV, Israel and RALEIGH, N.C., Jan. 14, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of its previously announced underwritten offering of 3,188,776 American Depositary Shares (ADSs) of the Company, at a price to the public of $7.84 per ADS. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company.

    RedHill Biopharma logo

    H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to additional 478,316 ADSs at the public offering price, less underwriting discounts and commissions.

    The gross proceeds to RedHill, before deducting…

    TEL AVIV, Israel and RALEIGH, N.C., Jan. 14, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of its previously announced underwritten offering of 3,188,776 American Depositary Shares (ADSs) of the Company, at a price to the public of $7.84 per ADS. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company.

    RedHill Biopharma logo

    H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to additional 478,316 ADSs at the public offering price, less underwriting discounts and commissions.

    The gross proceeds to RedHill, before deducting underwriting discounts and commissions and offering expenses, are approximately $25 million. The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.

    The securities described above were offered by RedHill pursuant to a "shelf" registration statement on Form F-3 (File No. 333-226278) previously filed with the Securities and Exchange Commission (the "SEC") on July 23, 2018 and declared effective by the SEC on July 31, 2018. The offering of the securities was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities offered have been filed with the SEC and are available on the SEC's website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements include statements regarding the intended use of net proceeds from the offering. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  8. TEL AVIV, Israel and RALEIGH, N.C., Jan. 11, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 1,275,510 American Depositary Shares (ADSs) of the Company, at a price to the public of $ $7.84 per ADS, less underwriting discounts and commissions. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. The closing of the offering is expected to occur on or about January 14, 2021, subject to satisfaction of customary closing conditions.

    TEL AVIV, Israel and RALEIGH, N.C., Jan. 11, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 1,275,510 American Depositary Shares (ADSs) of the Company, at a price to the public of $ $7.84 per ADS, less underwriting discounts and commissions. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. The closing of the offering is expected to occur on or about January 14, 2021, subject to satisfaction of customary closing conditions.

    H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

    The Company also has granted to the underwriter a 30-day option to purchase up to additional 191,326 ADSs at the public offering price, less underwriting discounts and commissions.

    The gross proceeds to RedHill, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter's option to purchase additional ADSs, are expected to be approximately $10 million. The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.

    The securities described above are being offered by RedHill pursuant to a "shelf" registration statement on Form F-3 (File No. 333-226278) previously filed with the Securities and Exchange Commission (the "SEC") on July 23, 2018 and declared effective by the SEC on July 31, 2018. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements include statements regarding: the completion of the offering, the satisfaction of customary closing conditions related to the offering and the intended use of net proceeds from the offering. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; market and other conditions and the satisfaction of customary closing conditions related to the offering; the risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    1. Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    2. Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    3. Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1-212-529-2236

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  9. TEL AVIV, Israel and RALEIGH, N.C,, Jan. 11, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or "the Company"), a specialty biopharmaceutical company, today reported that its partner, Cosmo Pharmaceuticals (SIX: COPN) ("Cosmo"), announced that it had successfully completed their Phase 2 Proof-of-Concept (POC) clinical trial of Rifamycin SV-MMX 600mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). 

    RedHill Biopharma logo

    As part of an exclusive license agreement between RedHill and Cosmo from October 2019 for the U.S. rights to Aemcolo® (rifamycin), RedHill maintains certain rights, including a right of first refusal, in relation to Rifamycin SV-MMX 600 mg in the U.S.

    Designed to address the debilitating effects of IBS-D…

    TEL AVIV, Israel and RALEIGH, N.C,, Jan. 11, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or "the Company"), a specialty biopharmaceutical company, today reported that its partner, Cosmo Pharmaceuticals (SIX: COPN) ("Cosmo"), announced that it had successfully completed their Phase 2 Proof-of-Concept (POC) clinical trial of Rifamycin SV-MMX 600mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). 

    RedHill Biopharma logo

    As part of an exclusive license agreement between RedHill and Cosmo from October 2019 for the U.S. rights to Aemcolo® (rifamycin), RedHill maintains certain rights, including a right of first refusal, in relation to Rifamycin SV-MMX 600 mg in the U.S.

    Designed to address the debilitating effects of IBS-D, Rifamycin SV-MMX is delivered at a 600mg dose and with different release features to Aemcolo®. Aemcolo® is approved for travelers' diarrhea (TD) caused by noninvasive strains of Escherichia coli (E. coli) in adults and promoted by RedHill for such use in the U.S.

    Cosmo reported that results of the Phase 2 POC study show the achievement of statistical significance in all the study populations (ITT, FAS, m-FAS and PP) for the composite primary endpoint (substantial pain and diarrhea decrease) [OR 3.26 (1.39 – 7.67); p-value 0.0066] and for most secondary endpoints such as adequate relief of IBS-related symptoms [OR 2.18 (1.12 – 4.26); p-value 0.0227] and IBS-related bloating at the end of treatment period [OR 2.13 (1.11 – 4.07); p-value 0.0223].

    "We are delighted for our partner, Cosmo, on the positive outcome of this study, which clearly demonstrates the potential for Rifamycin SV-MMX 600mg, if approved, to be an important treatment option in tackling IBS-D," said Dror Ben-Asher, RedHill's CEO.

    About Aemcolo® (rifamycin)

    Aemcolo® (rifamycin) is an orally-administered, delayed-release, non-systemic antibiotic approved for the treatment of travelers' diarrhea caused by non-invasive strains of Escherichia coli (E. coli) in adults. Aemcolo® is the first antibiotic engineered with Cosmo Pharmaceuticals' Multi Matrix Technology (MMX®). MMX technology is designed to deliver the active pharmaceutical ingredients in a delayed and controlled manner directly to the lower intestine.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    Aemcolo® is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli (E. coli) in adults.

    Limitations of Use

    Aemcolo® is not indicated in patients with diarrhea complicated by fever or bloody stool or due to pathogens other than noninvasive strains of E. coli.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Aemcolo® and other antibacterial drugs, Aemcolo® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

    CONTRAINDICATION

    Aemcolo® is contraindicated in patients with a known hypersensitivity to rifamycin, any of the other rifamycin class antimicrobial agents, or any of the components in Aemcolo®.

    WARNINGS AND PRECAUTIONS

    Risk of Persistent or Worsening Diarrhea Complicated by Fever and/or Bloody Stool

    Aemcolo® was not shown to be effective in patients with diarrhea complicated by fever and/or bloody stool or diarrhea caused by pathogens other than E. coli and is not recommended for use in such patients.

    Discontinue Aemcolo® if diarrhea gets worse or persists more than 48 hours and consider alternative antibacterial therapy.

    Clostridium difficile-Associated Diarrhea (CDAD)

    CDAD has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

    Consider CDAD in all patients who present with diarrhea following antibacterial drug use. Careful

    medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

    Development of Drug-Resistant Bacteria

    Prescribing Aemcolo® in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

    ADVERSE REACTIONS

    Discontinuation of Aemcolo® due to adverse reactions occurred in 1% of patients. The most frequent adverse reactions were abdominal pain (0.5%) and pyrexia (0.3%).

    Adverse reactions that occurred in at least 2% of Aemcolo®-treated patients and with a higher incidence than in the placebo or ciprofloxacin groups were constipation 3.5% and headache 3.3%, respectively.

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    There are no available data on AEMCOLO use in pregnant women to inform any drug associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.

    Lactation

    There is no information regarding the presence of AEMCOLO in human milk, the effects on the breastfed infant, or the effects on milk production.

    Pediatric Use

    The safety and effectiveness of AEMCOLO has not been established in pediatric patients <18 years of age.

    See Full prescribing information for Aemcolo® is available at www.aemcolo.com  

    To submit adverse event reports or product complaint reports, contact RedHill Biopharma, Inc. at 1(833)-ADR-HILL. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088).

    About RedHill Biopharma

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation risks related to the commencement or the timing of our clinical trials with RHB-102 (Bekinda®) and ABC294640 (Yeliva®), as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its therapeutic candidates; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, Aemcolo®, and Movantik® ; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on February 26, 2019, as amended on May 15, 2019. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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  10. TEL AVIV, Israel and RALEIGH, NC, Jan. 6, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or "the Company"), a specialty biopharmaceutical company, today announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy.

    RedHill Biopharma Logo

    The FDA's Fast Track designation is designed to help progress development and speed up the review of novel therapies for serious conditions for which there is an unmet medical need - with the aim of getting important new…

    TEL AVIV, Israel and RALEIGH, NC, Jan. 6, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or "the Company"), a specialty biopharmaceutical company, today announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy.

    RedHill Biopharma Logo

    The FDA's Fast Track designation is designed to help progress development and speed up the review of novel therapies for serious conditions for which there is an unmet medical need - with the aim of getting important new therapies to patients more quickly. With the Fast Track designation, RedHill will have access to early and frequent communications with the FDA, to expedite the RHB-204 development program, and to a rolling review of a New Drug Application (NDA). Having already been granted Qualified Infectious Disease Product (QIDP) designation, RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.

    RHB-204 was also recently granted Orphan Drug designation, extending U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.

    RedHill recently initiated a Phase 3 study evaluating the safety and efficacy of RHB-204 as a first-line treatment for pulmonary NTM disease, to be conducted at up to 40 sites across the U.S. 

    "Given the urgent need to improve therapeutic options for patients with NTM disease, we welcome this Fast Track designation and the regulatory support it provides in expediting the ongoing Phase 3 development program for RHB-204 and any subsequent potential approvals," said Patricia Anderson, RedHill's Senior Vice President of Regulatory Affairs. "NTM disease is thankfully rare but its prevalence is increasing in many areas of the world. It is a notoriously difficult to treat disease and, if not effectively treated, can cause scarring and fibrosis in the lungs - potentially leading to respiratory failure. Many patients fail current therapies, and more than half will have either recurring disease or a new infection after completing treatment [1],[2]."

    RHB-204 may be eligible for use under the RedHill expanded access policy – more details of which can be found here: https://www.redhillbio.com/expandedaccess. The Phase 3 study of RHB-204 is registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies. 

    About Pulmonary Nontuberculous Mycobacteria (NTM) Disease

    Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic and debilitating lung disease caused by ubiquitous environmental bacteria found in soil, as well as natural and engineered water systems. The most common NTM symptoms include fever, weight loss, chest pain, and blood in sputum[3]. Pulmonary NTM disease can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure[4]. Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world[5]. There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 2017, with U.S. market potential estimated at over $500 million[6]. Pulmonary manifestations account for 80-90% of all NTM-associated diseases[7], and approximately 80% of pulmonary NTM disease are caused by Mycobacterium avium Complex (MAC)[8].

    About RHB-204

    RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC). In addition to FDA Fast Track designation, RHB-204 has been granted FDA Orphan Drug designation for the treatment of NTM disease and QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. market exclusivity for RHB-204 to a potential total of 12 years to be granted at the time of FDA approval. RHB-204 is also covered by U.S. patents which extend patent protection until 2029 and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[9], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[10], and Aemcolo® for the treatment of travelers' diarrhea in adults[11]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    References:

    [1] Henkle E, et al. Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Research Consortium Workshop Report Annals of the American Thoracic Society 2016; S379-84.

    [2] Daley CL, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline: Executive Summary. Clinical Infectious Diseases. Ciaa241, https://doi.org/10.1093/cid/ciaa241.

    [3] Kim RD, et al. Pulmonary Nontuberculous Mycobacterial Disease. Prospective Study of a Distinct Preexisting Syndrome Am J Respir Crit Care Med. 2008; 178(10):1066–74.

    [4] The American Lung Association, 2020.

    [5] Henkle E, et al. Population-based Incidence of Pulmonary Nontuberculous Mycobacterial Disease in Oregon 2007 to 2012 Annals of the American Thoracic Society. 2015; 12(5):642-7.

    [6] Foster|Rosenblatt, 2017.

    [7] Griffith DE, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases Am J Respir Crit Care Med. 2007;175(4):367-416.

    [8] Prevots DR et al. Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. Am J Respir Crit Care Med 2010; 182:970-76; Winthrop KL, et al. Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. Am J Respir Crit Care Med 2010; 182: 977-82

    [9] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [10] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [11] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

     

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    SOURCE RedHill Biopharma Ltd.

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  11. TEL AVIV, Israel and RALEIGH, N.C., Dec. 31, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that preliminary top-line data from its U.S. Phase 2 study with orally-administered opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with COVID-19 pneumonia demonstrated positive safety and efficacy signals.

    The randomized, double-blind, placebo-controlled U.S. Phase 2 proof-of-concept study with opaganib (NCT04414618) enrolled 40 patients requiring oxygen support. The study was not powered for statistical significance and aimed to evaluate safety and identify preliminary signs of activity. Patients in the study were randomized at a 1:1 ratio to receive either opaganib or placebo on top of standard-of-care (SoC) and were followed up for up to 42 days post treatment initiation.

    • Top-line results from the study found opaganib to be safe, with no material safety differences between the opaganib and placebo treatment arms. Overall, fewer patients suffered from serious adverse events (SAEs) in the opaganib treatment arm than in the placebo arm. In this small sample size, there were few events of intubation or fatality and these were balanced between the two arms.
    • The opaganib-treated arm demonstrated a consistent trend of greater improvement in reducing oxygen requirement by end of treatment on Day 14 across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale:

      - A greater improvement in the proportion of patients reaching room air and no longer requiring oxygen support by Day 14 vs. the control arm (52.6% vs. 22.2%).

      - A greater improvement in the proportion of patients with 50% reduction in supplemental oxygen by day 14 vs. the control arm (89.5% vs. 66.7%).

      - A higher proportion of patients discharged by Day 14 vs. the control arm (73.7% vs. 55.6%).

      - A greater reduction from baseline of the median total oxygen requirement (AUC) over 14 days vs. the control arm (68.0% vs. 46.7%).

    Full analysis of the data, including viral and inflammatory biomarker analyses, baseline risk factors and SoC background therapy stratifications, is expected in the coming weeks. The Company will provide the data for peer review when available.

    "We are pleased with these encouraging top-line results from our exploratory Phase 2 study which confirm opaganib's safety and demonstrate promising signals of activity when treating patients with COVID-19 and who require oxygen support. These preliminary results support our ongoing global Phase 2/3 study in severe COVID-19 pneumonia, which is expected to read out in Q1/2021. We continue to work diligently to compile a robust data set to support potential filing of global emergency use applications," said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill.

    Gilead Raday, RedHill's Chief Operating Officer, added: "Opaganib has a unique dual mode of action that is both anti-inflammatory and antiviral – acting on both the cause and the effects of COVID-19. Opaganib targets sphingosine kinase-2, a human cell component involved in viral replication and not the virus itself. The mounting evidence of new SARS-CoV-2 mutations emerging globally underscores the importance of this unique mechanism, which potentially minimizes the risk of viral resistance to therapy. The trends of patient improvement shown by the preliminary top-line data support the ongoing Phase 2/3 study with opaganib, which will provide a more in-depth understanding of opaganib's activity."

    The efficacy of opaganib in severe COVID-19 pneumonia is being further explored in an ongoing global Phase 2/3 study and is expected to report top-line data in the first quarter of 2021. This study (NCT04467840) is being conducted across approximately 30 clinical sites in several countries and is on track to enroll up to 270 patients. The study has undergone two unblinded reviews of safety data by an independent Data and Safety Monitoring Board (DSMB), with unanimous recommendations to continue the study. An interim DSMB futility analysis will be conducted in the coming weeks, evaluating data from the first 135 subjects that have reached the primary endpoint.

    The top-line results from the U.S. Phase 2 study of opaganib in patients hospitalized with COVID-19 pneumonia are preliminary and were provided to the Company by an independent third-party following an initial independent analysis and remain subject to additional review and analysis. Such review and analysis may result in findings inconsistent with the results disclosed in this release and may not be replicated in future studies.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study and has demonstrated positive safety and efficacy signals in preliminary top-line data from a U.S. Phase 2 study.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to ameliorate inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults with non-cancer pain[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage investigational development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and includes statements regarding the timing of the reporting of a full analysis of the data from the U.S. Phase 2 trial evaluating opaganib, the timing of potential emergency use applications for opaganib and the timing of reporting of top-line data, safety analysis and of unblinded futility interim analysis for the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be successful; the risk of a delay in receiving top-line data from the Phase 2/2 study and in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the full analysis of data from the U.S. Phase 2 clinical study evaluating opaganib will be delayed or will differ from the preliminary data; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment, reporting of top-line data, safety analysis and/or unblinded futility interim analysis will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1-212-529-2236

    1. Opaganib is an investigational new drug, not available for commercial distribution.

    2. Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    3. Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    4. Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    5. Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  12. TEL AVIV, Israel and RALEIGH, N.C., Dec. 22, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a second unanimous recommendation to continue, following a second independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's recommendation is based on an analysis of unblinded safety data from the first 155 patients treated for 14 days.

    RedHill Biopharma logo

    "This second unanimous independent DSMB recommendation to continue the global Phase 2/3 study of opaganib in patients with severe COVID-19 confirms the…

    TEL AVIV, Israel and RALEIGH, N.C., Dec. 22, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with orally-administered opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a second unanimous recommendation to continue, following a second independent Data Safety Monitoring Board (DSMB) safety review. The DSMB's recommendation is based on an analysis of unblinded safety data from the first 155 patients treated for 14 days.

    RedHill Biopharma logo

    "This second unanimous independent DSMB recommendation to continue the global Phase 2/3 study of opaganib in patients with severe COVID-19 confirms the safety of opaganib and means we can continue to focus on completing enrollment for this study as rapidly as possible, with a view to having top-line data in the first quarter of 2021. If successful, we expect to make subsequent global emergency use applications the same quarter," said Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill.

    Enrollment in the 270-patient global Phase 2/3 study of orally-administered opaganib in hospitalized patients with severe COVID-19 pneumonia (NCT04467840) is more than 60% complete, and is on track to deliver top-line data in the first quarter of 2021. This study is focused on and powered for efficacy evaluation. A pre-scheduled, unblinded futility interim analysis will be conducted by the DSMB in the coming weeks, evaluating data from the first 135 subjects that have reached the primary endpoint.

    The parallel U.S. Phase 2 study with opaganib (NCT04414618) has completed enrollment of all 40 subjects, with top-line data expected by year's end. This study is not powered for efficacy and is focused on safety evaluation and potential identification of preliminary efficacy signals.

    Opaganib is a novel, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with a preclinically demonstrated triple-action mechanism that inhibits viral replication, reduces hyper-immune inflammatory response and diminishes ARDS-related thrombosis (blood clots) – a dangerous complication of COVID-19 disease – in effect acting on the cause and effect of COVID-19 disease. Opaganib's target is a human host cell component involved in viral replication, potentially minimizing the likelihood of resistance due to viral mutations.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with a demonstrated unique triple-action effect on the pathophysiological processes associated with COVID-19 disease, that targets a host cell component, potentially minimizing the likelihood for resistance due to viral mutations. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory and gastrointestinal indications.

    Opaganib is being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of severe COVID-19 pneumonia. Opaganib also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    Under a compassionate use program, patients with severe COVID-19 (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published[3]. Analysis of treatment outcomes suggests substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases;  and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the timing of the reporting of data from the U.S. Phase 2 trial evaluating opaganib, and the timing, if at all, of potential emergency use applications of opaganib and reporting of data, from the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be completed or successful; the risk of a delay in receiving data from the Phase 2/3 study with opaganib or delay in making emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the reporting of data from this clinical study will be delayed, if at all; the risk that other COVID-19 patients treated with opaganib will not show any or insufficient clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs; the risk that the ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease will be delayed, not be completed, or will not be successful, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the lack of sufficient financial resources which may result in material adverse impact on the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development activities including delay or termination of preclinical or clinical activities or of any other such activities (iii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iv) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [3] Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate Use of Opaganib For Patients with Severe COVID-19. medRxiv 2020.06.20.20099010; doi: https://doi.org/10.1101/2020.06.20.20099010

    [4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    Cision View original content:http://www.prnewswire.com/news-releases/redhills-phase-23-covid-19-study-of-opaganib-passes-second-dsmb-with-unanimous-recommendation-to-continue-301197482.html

    SOURCE RedHill Biopharma Ltd.

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  13. TEL AVIV, Israel and RALEIGH, N.C., Dec. 15, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced promising preliminary results from a preclinical study within which opaganib, a novel, orally administered sphingosine kinase 2 (SK2) selective inhibitor, (administered at 250mg/kg,) demonstrating a reduction of thrombosis (blood clotting) in an acute respiratory distress syndrome (ARDS) – a preclinical animal model designed to measure thrombotic (blood clot) risks.

    This latest finding points towards another important potential benefit of opaganib to COVID-19 patients – in addition to the already established inhibition of SARS-CoV-2 replication and the potential…

    TEL AVIV, Israel and RALEIGH, N.C., Dec. 15, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced promising preliminary results from a preclinical study within which opaganib, a novel, orally administered sphingosine kinase 2 (SK2) selective inhibitor, (administered at 250mg/kg,) demonstrating a reduction of thrombosis (blood clotting) in an acute respiratory distress syndrome (ARDS) – a preclinical animal model designed to measure thrombotic (blood clot) risks.

    This latest finding points towards another important potential benefit of opaganib to COVID-19 patients – in addition to the already established inhibition of SARS-CoV-2 replication and the potential reduction in hyper immune-response by opaganib. Following these preliminary findings, additional work is being planned to evaluate the range of potential physiologically and pharmacologically relevant opaganib doses with respect to thrombosis reduction.

    RedHill Biopharma logo

    "Acute Respiratory Distress Syndrome (ARDS) is one of the most dangerous outcomes of COVID-19 disease, putting severely ill COVID-19 patients at an increased risk of potentially fatal venous thrombosis and pulmonary embolism.  There are currently very limited options available to physicians that have been shown to be effective against ARDS, and specifically against ARDS-induced thrombosis," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "Results from our study show opaganib 250 mg/kg reduced blood clot length, weight and total thrombus score in a preclinical model of ARDS. This adds to the known antiviral and anti-inflammatory activities of opaganib and provides the potential for a unique triple-action effect on the pathophysiological processes associated with COVID-19 disease. Opaganib, which targets a host cell component, potentially minimizes the likelihood for resistance due to viral mutations. Before the end of this month, we expect topline clinical data insights into the safety and potential efficacy signals of opaganib from the non-powered U.S. Phase 2 study in which the last patient has been given their last dose on November 26, followed in Q1/2021 by top-line data from the larger global Phase 2/3 study, which is powered for efficacy and already more than 60% enrolled."

    "The ARDS thrombosis model we used to conduct this work is validated and highly predictive, and the results we saw with opaganib are impressive and provide reason for promise," said Sebastien Labbe, Ph.D., Director, Translational Research at IPS Therapeutique Inc., who carried out the study. "The results provide insight into a highly desirable potential effect of opaganib for use in managing patients with severe COVID-19, whose prognosis can be very poor."  

    ARDS-induced thrombosis may occur in up to one-third of COVID-19 patients requiring Intensive Care Unit (ICU) admission and up to 9% of all hospitalized patients[1] and is associated with a poor prognosis. The preclinical study was designed to assess the efficacy of opaganib in reducing the incidence of adverse thromboembolic events in situ in the lipopolysaccharide (LPS)-induced model of pulmonary inflammation, a reliable model of ARDS that can mimic COVID-19 inflammation[2].

    The results from the preclinical study of opaganib are preliminary and were provided to the Company by an independent third-party following an initial independent analysis and remain subject to additional review and analysis. Such review and analysis may result in findings inconsistent with the results disclosed in this release and may not be replicated in future preclinical or clinical studies.

    Opaganib is a novel, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that acts on both the cause and the effects of COVID-19 disease, targeting a host cell component involved in viral replication, potentially minimizing likelihood of resistance due to viral mutations.

    A U.S. Phase 2 study with opaganib in patients with severe COVID-19 pneumonia (NCT04414618) has completed enrollment of all 40 subjects, and the last patient has been given their last dose – top-line data is expected later this month. This Phase 2 study is not powered for efficacy and is focused on safety evaluation and identification of efficacy signals.

    In parallel, enrollment in the 270-patient global Phase 2/3 study with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) is over 60% complete. The study is approved in six countries and is on track to deliver topline data in the first quarter of 2021. This study is focused on and powered for efficacy evaluation, and recently received a unanimous recommendation to continue by an independent Data and Safety Monitoring Board (DSMB), following a pre-scheduled safety review of the first 70 patients to have been treated for 14 days. The DSMB is scheduled to conduct a second pre-planned safety review this month of the first 135 patients who have reached the primary endpoint, and this will later be followed by a prescheduled, unblinded futility interim analysis of efficacy data from the same patients. The Company will remain blinded to this data.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with a demonstrated unique triple-action effect on the pathophysiological processes associated with COVID-19 disease, that targets a host cell component, potentially minimizing the likelihood for resistance due to viral mutations. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory and gastrointestinal indications.

    Opaganib is being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of severe COVID-19 pneumonia. Opaganib also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies[3] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    Under a compassionate use program, patients with severe COVID-19 (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published[4]. Analysis of treatment outcomes suggests substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[5], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[6], and Aemcolo® for the treatment of travelers' diarrhea in adults[7]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases;  and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the timing of the reporting of data from the U.S. Phase 2 trial evaluating opaganib, and the timing, if at all, of potential emergency use applications of opaganib and reporting of data, from the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be completed or successful; the risk of a delay in receiving data from the Phase 2/3 study with opaganib or delay in making emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the reporting of data from this clinical study will be delayed, if at all; the risk that other COVID-19 patients treated with opaganib will not show any or insufficient clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs; the risk that the ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease will be delayed, not be completed, or will not be successful, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the lack of sufficient financial resources which may result in material adverse impact on the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development activities including delay or termination of preclinical or clinical activities or of any other such activities (iii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iv) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    [1] Sakr, Y., Giovini, M., Leone, M. et al. Pulmonary embolism in patients with coronavirus disease-2019 (COVID-19) pneumonia: a narrative review. Ann. Intensive Care 10, 124 (2020). https://doi.org/10.1186/s13613-020-00741-0.

    [2] https://blog.covance.com/2020/08/using-acute-respiratory-disease-syndrome-ards-in-vivo-models-to-screen-for-coronavirus-inflammation-treatment/

    [3] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [4] Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate Use of Opaganib For Patients with Severe COVID-19. medRxiv 2020.06.20.20099010; doi: https://doi.org/10.1101/2020.06.20.20099010

    [5] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [6] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [7] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    Cision View original content:http://www.prnewswire.com/news-releases/redhills-phase-23-covid-19-candidate-opaganib-reduces-ards-related-blood-clotting-in-preclinical-model-301193097.html

    SOURCE RedHill Biopharma Ltd.

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  14. TEL AVIV, Israel and RALEIGH, N.C., Dec. 14, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the company was selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI). The addition to the NBI will become effective prior to market open on Monday, December 21, 2020.

    RedHill Biopharma logo

    The Index is used to designate a set of NASDAQ-listed securities to be acquired as part of index-defined funds to be used in investment portfolios. The biotechnology index is classified according to the Industry Classification Benchmark (ICB). Companies in the biotechnology index must meet eligibility requirements, including minimum market capitalization, average daily trading…

    TEL AVIV, Israel and RALEIGH, N.C., Dec. 14, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the company was selected for addition to the NASDAQ Biotechnology Index (NASDAQ:NBI). The addition to the NBI will become effective prior to market open on Monday, December 21, 2020.

    RedHill Biopharma logo

    The Index is used to designate a set of NASDAQ-listed securities to be acquired as part of index-defined funds to be used in investment portfolios. The biotechnology index is classified according to the Industry Classification Benchmark (ICB). Companies in the biotechnology index must meet eligibility requirements, including minimum market capitalization, average daily trading volume, seasoning as a public company, and other criteria. The index is evaluated annually and serves as the basis for the iShares NASDAQ Biotechnology Index Fund.

    For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit https://indexes.nasdaqomx.com/.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults with non-cancer pain[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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  15. TEL AVIV, Israel and RALEIGH, N.C., Dec. 7, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has increased unrestricted national and regional commercial coverage for Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1] to more than 40 million additional Americans.

    "With this addition of unrestricted coverage for over 40 million more lives, Talicia is now available to over 70% of commercial lives. The unrestricted commercial coverage achieved for Talicia to date far exceeds our expectations at such an early stage following the product's launch. We continue to work diligently to increase unrestricted coverage of Talicia, in an effort to make a significant difference in ending sub-optimal treatment of H. pylori," said Rick Scruggs, RedHill's Chief Commercial Officer. "Antibiotic resistance is a major issue in the treatment of H. pylori infections and yet, despite current guideline recommendations from the American College of Gastroenterology calling for use of the most effective first-line treatment, physicians are still prescribing treatment regimens containing antibiotics such as clarithromycin that face high levels of bacterial resistance. This growth in unrestricted commercial access helps change that dynamic by increasing access to Talicia to more than 167 million Americans."

    RedHill has previously announced listings of Talicia as a preferred brand on the national formularies of Prime Therapeutics, EnvisionRx, and Express Scripts.

    About Talicia (omeprazole magnesium, amoxicillin and rifabutin)

    Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to clarithromycin-based standard-of-care therapies. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based standard-of-care therapy and are a strong public health concern, as highlighted by the FDA and the World Health Organization (WHO) in recent years.

    Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to Talicia was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[2] to their therapy had response rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm[3].

    Talicia is eligible for a total of eight years of post-approval U.S. market exclusivity under both its Qualified Infectious Disease Product (QIDP) designation and New Clinical Investigation exclusivities. In addition, Talicia is protected by a robust U.S. patent portfolio which provides patent protection until at least 2034, with additional patents and applications pending and granted in various territories worldwide. 

    About H. pylori

    H. pylori bacterial infection affects approximately 35%[4] of the U.S. population, with an estimated two million patients treated annually[5]. Worldwide, more than 50% of the population is affected by H. pylori infection, which is classified by the WHO as a Group 1 carcinogen, remains the strongest known risk factor for gastric cancer[6] and a major risk factor for peptic ulcer disease[7] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[8]. More than 27,000 Americans are diagnosed with gastric cancer annually[9], while eradication of H. pylori has been shown to reduce the risk of gastric cancer by up to 75%[10]. Eradication of H. pylori is becoming increasingly difficult, with current standard-of-care therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics commonly used in standard combination therapies[11].

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[12], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[13], and Aemcolo® for the treatment of travelers' diarrhea in adults[14]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases; and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    IMPORTANT SAFETY INFORMATION

    Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycins.

    Talicia is contraindicated in patients receiving delavirdine, voriconazole or rilpivirine-containing products.

    Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.

    Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.

    Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.

    Talicia may cause fetal harm and is not recommended for use in pregnancy. It may also reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.

    Talicia should not be used in patients with hepatic impairment or severe renal impairment.

    Cutaneous lupus erythematosus and systemic lupus erythematosus have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.

    The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

    To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at

    1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Full prescribing information for Talicia is available at www.Talicia.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties including, without limitation, the risk that the Company will be unable to secure additional pharmacy benefit management's formulary coverage for Talicia®, as well as other risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials, including the development of a commercial companion diagnostic for the detection of MAP; (iii) the lack of sufficient financial resources which may result in material adverse impact on the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development activities including delay or termination of preclinical or clinical activities or of any other such activities (iv) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (v) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (vi) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and commercial products; (vi) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) the hiring and maintaining employment of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    1. Talicia® (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg/250 mg/12.5 mg is indicated for the treatment of Helicobacter pylori (H. pylori) infection in adults. For full prescribing information see: www.Talicia.com.

    2. Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.

    3. The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).

    4. Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.

    5. IQVIA Custom Study for RedHill Biopharma, 2019

    6. Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.

    7. NIH – Helicobacter pylori and Cancer, September 2013.

    8. Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.

    9. National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).

    10. Kumar S et al. Risk Factors and Incidence of Gastric Cancer After Detection of Helicobacter pylori Infection: A Large Cohort Study. Gastroenterology 2020; 158: 527-536.

    11. Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.

    12. Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com

    13. Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    14. Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

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    SOURCE RedHill Biopharma Ltd.

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  16.  

     

     

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 25, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced partnerships with two leading, U.S.-based manufacturers for large-scale manufacturing of opaganib[1]. These collaborations further advance ongoing preparations to support potential emergency use applications for opaganib to treat severe COVID-19 pneumonia, expected as early as the first quarter of 2021. The new collaborations follow recently announced collaborations with European and Canadian manufacturers.

     

    RedHill Biopharma Logo

     

    "We are expanding our U.S.-based manufacturing capacity for orally administered opaganib, ahead of potential emergency use applications…

     

     

     

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 25, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced partnerships with two leading, U.S.-based manufacturers for large-scale manufacturing of opaganib[1]. These collaborations further advance ongoing preparations to support potential emergency use applications for opaganib to treat severe COVID-19 pneumonia, expected as early as the first quarter of 2021. The new collaborations follow recently announced collaborations with European and Canadian manufacturers.

     

    RedHill Biopharma Logo

     

    "We are expanding our U.S.-based manufacturing capacity for orally administered opaganib, ahead of potential emergency use applications as early as Q1/2021," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "Together with our recently announced similar partnerships in Europe and Canada and in light of our rapidly progressing Phase 2/3 opaganib COVID-19 program, these new U.S. partnerships better place RedHill to meet potential demand for opaganib, if approved."

    Opaganib is a novel, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that acts on the cause and effect of  COVID-19 disease, targeting a host cell component involved in viral replication, potentially minimizing likelihood of resistance due to viral mutations.

    Enrollment in the 270-patient global Phase 2/3 study with opaganib in patients with severe  COVID-19 pneumonia (NCT04467840) is more than 50% complete. The study is approved in six countries and is on track to deliver top-line data in the first quarter of 2021. This study is focused on and powered for efficacy evaluation, and recently received a unanimous recommendation to continue by an independent Data and Safety Monitoring Board (DSMB), following a pre-scheduled safety review of the first 70 patients to have been treated for 14 days. A prescheduled, unblinded futility interim analysis will also be conducted by the DSMB in the coming weeks, evaluating data from the first 135 subjects that have reached the primary endpoint.

    The parallel U.S. Phase 2 study with opaganib (NCT04414618) has completed enrollment of all 40 subjects, with topline data expected in the coming weeks. This study is not powered for efficacy and is focused on safety evaluation and identification of efficacy signals.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood for resistance due to viral mutations. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory and gastrointestinal indications.

    Opaganib is being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of severe COVID-19 pneumonia. Opaganib also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    Under a compassionate use program, patients with severe COVID-19 (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published[3]. Analysis of treatment outcomes suggest substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases;  and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the timing of the reporting of data from the U.S. Phase 2 trial evaluating opaganib, the timing, if at all, of potential emergency use applications of opaganib and reporting of data, from the global Phase 2/3 study with opaganib and regarding the planned Phase 2/3 study for RHB-107 in symptomatic COVID-19 patients. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be completed or successful; the risk of a delay in receiving data from the Phase 2/3 study with opaganib or delay in making emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the reporting of data from this clinical study will be delayed if at all; the risk that the planned Phase 2/3 study for RHB-107 in symptomatic COVID-19  patients will not occur, will be delayed or will not be completed or successful; the risk that other COVID-19 patients treated with opaganib or RHB-107 will not show any or insufficient clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib and RHB-107 for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs; the risk that the ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease will be delayed, not be completed, or will not be successful, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the lack of sufficient financial resources which may result in material adverse impact on the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development activities including delay or termination of preclinical or clinical activities or of any other such activities (iii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iv) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (v) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (vi) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vii) the Company's ability to establish and maintain corporate collaborations; (viii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (ix) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (x) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (xi) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xii) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    [1] Opaganib (Yeliva, ABC294640) is an investigational new drug, not commercially available

    [2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [3] Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate Use of Opaganib For Patients with Severe COVID-19. medRxiv 2020.06.20.20099010; doi: https://doi.org/10.1101/2020.06.20.20099010

    [4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  17. TEL AVIV, Israel and RALEIGH, N.C., Nov. 23, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present and participate at the following virtual conferences in December:

    RedHill Biopharma Logo

    Evercore ISI 3rd Annual HealthCONx Conference
    Fireside chat and an open Q&A: Thursday, December 3, 2020, 8 a.m. EST
    Moderator: Umer Raffat, Equity Research – Biotech-large, Pharma-major, Specialty Pharma
    Speaker: Dror Ben-Asher, CEO & Gilead Raday, Chief Operating Officer

    Piper Sandler 32nd Annual Virtual Healthcare Conference
    Fireside chat: Available on-demand from November 23, 2020
    Moderator: David Amsellem, Managing Director, Sr. Research Analyst, Specialty Pharma
    Speaker:

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 23, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present and participate at the following virtual conferences in December:

    RedHill Biopharma Logo

    Evercore ISI 3rd Annual HealthCONx Conference

    Fireside chat and an open Q&A: Thursday, December 3, 2020, 8 a.m. EST

    Moderator: Umer Raffat, Equity Research – Biotech-large, Pharma-major, Specialty Pharma

    Speaker: Dror Ben-Asher, CEO & Gilead Raday, Chief Operating Officer

    Piper Sandler 32nd Annual Virtual Healthcare Conference

    Fireside chat: Available on-demand from November 23, 2020

    Moderator: David Amsellem, Managing Director, Sr. Research Analyst, Specialty Pharma

    Speaker: Guy Goldberg, Chief Business Officer

    The webcasts will be available for replay for 30 days on the Company's website: https://ir.redhillbio.com.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults with non-cancer pain[1], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[2], and Aemcolo® for the treatment of travelers' diarrhea in adults[3]. RedHill's key clinical late-stage investigational development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    [1] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [2] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [3] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

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    SOURCE RedHill Biopharma Ltd.

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  18. TEL AVIV, Israel and RALEIGH, N.C., Nov. 20, 2020 /PRNewswire/ --  RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or "the Company"), a specialty biopharmaceutical company, today announced that it has initiated its Phase 3 study to evaluate the safety and efficacy of RHB-204 as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by  Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy.

    "NTM is a debilitating disease that can cause scarring, fibrosis and the formation of cavities or pits in the lungs, which can lead to potentially fatal respiratory failure. People with existing lung conditions, such as bronchiectasis and those with COPD, are particularly susceptible," said Prof. Kevin Winthrop, MD, MPH, Professor of Infectious Diseases, Oregon Health & Science University, and study Principal Investigator. "NTM is notoriously resistant to most antibiotics and challenging to treat, and there is no FDA-approved first-line therapy for the approximately 110,000 cases of NTM infection in the U.S. This study of orally-administered RHB-204, if successful, represents an opportunity to make a breakthrough in managing NTM infections."

    "Treatment of NTM disease requires multiple antibiotics and an extended treatment course due to the risk of development of resistance1," said Aida Bibliowicz, RedHill's Vice President of Clinical Affairs. "Many patients fail these types of therapies and more than half will have either recurring disease or a new infection after completing treatment2, making new treatment options for NTM an urgent need."

    The multi-center, randomized, double-blind, two-part, placebo-controlled, parallel-group Phase 3 study will be conducted at up to 40 sites across the U.S. and aims to enroll 125 patients, randomized at a 3:2 ratio to receive either RHB-204 or placebo. The study is designed to evaluate the safety and efficacy of RHB-204 in patients with symptomatic Mycobacterium avium Complex (MAC) lung disease. Study endpoints include sputum culture conversion at month six of treatment with RHB-204, compared to placebo and patient-reported outcomes, including improvements in physical functioning, respiratory symptoms and fatigue. Following this assessment (part one of the study), patients may be eligible to continue double-blinded treatment for up to 16 months (part two). Sustainability of clinical benefit and durability of microbiological response will be assessed at month 16 and again three months after treatment completion.

    RHB-204 was recently granted Orphan Drug designation, extending U.S. market exclusivity for RHB-204 by an additional seven years, for a potential total of 12 years upon FDA approval. RHB-204 had also previously been granted a Qualified Infectious Disease Product (QIDP) designation by the FDA, providing eligibility for Fast-Track development, NDA Priority Review and a five-year extension of U.S. market exclusivity, if approved.

    The Phase 3 study of RHB-204 is registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About Pulmonary Nontuberculous Mycobacteria (NTM) Disease

    Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic and debilitating lung disease caused by ubiquitous environmental bacteria found in soil, as well as natural and engineered water systems. The most common NTM symptoms include fever, weight loss, chest pain, and blood in sputum3. Pulmonary NTM disease can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure4. Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world5. There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 20176. Pulmonary manifestations account for 80-90% of all NTM-associated diseases7, and approximately 80% of pulmonary NTM disease are caused by Mycobacterium avium Complex (MAC)8.

    About RHB-204

    RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC). RHB-204 was granted both FDA Orphan Drug designation for the treatment of NTM disease and QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. market exclusivity for RHB-204 to a potential total of 12 years to be granted at the time of FDA approval. RHB-204 is also covered by U.S. patents which extend patent protection until 2029 and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041.      

    About RedHill Biopharma   



    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults9, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults10, and Aemcolo® for the treatment of travelers' diarrhea in adults11. RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage serine protease inhibitor with a planned Phase 2/3 study in symptomatic COVID-19 and targeting multiple other cancer and inflammatory gastrointestinal diseases;  and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk that the Company will not succeed to complete the patient recruitment; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    1. Daley CL, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline: Executive Summary. Clinical Infectious Diseases. Ciaa241, https://doi.org/10.1093/cid/ciaa241.
    2. Henkle E, et al. Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Research Consortium Workshop Report Annals of the American Thoracic Society 2016; S379-84.
    3. Kim RD, et al. Pulmonary Nontuberculous Mycobacterial Disease. Prospective Study of a Distinct Preexisting Syndrome Am J Respir Crit Care Med. 2008; 178(10):1066–74.
    4. The American Lung Association, 2020.
    5. Henkle E, et al. Population-based Incidence of Pulmonary Nontuberculous Mycobacterial Disease in Oregon 2007 to 2012 Annals of the American Thoracic Society. 2015; 12(5):642-7.
    6. Foster|Rosenblatt, 2017.
    7. Griffith DE, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases Am J Respir Crit Care Med. 2007;175(4):367-416.
    8. Prevots DR et al. Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. Am J Respir Crit Care Med 2010; 182:970-76; Winthrop KL, et al. Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. Am J Respir Crit Care Med 2010; 182: 977-82
    9. Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  
    10. Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       
    11. Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  19. TEL AVIV, Israel and RALEIGH, N.C., Nov. 19, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a pre-scheduled safety review by an independent Data and Safety Monitoring Board (DSMB). The DSMB's recommendation is based on an unblinded analysis of safety data from the first 70 patients treated for 14 days.

    RedHill Biopharma Logo

    "With each review of unblinded safety data, by independent reviewers, as part of our development program, our confidence in the safety profile of opaganib increases…

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 19, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a pre-scheduled safety review by an independent Data and Safety Monitoring Board (DSMB). The DSMB's recommendation is based on an unblinded analysis of safety data from the first 70 patients treated for 14 days.

    RedHill Biopharma Logo

    "With each review of unblinded safety data, by independent reviewers, as part of our development program, our confidence in the safety profile of opaganib increases further," said Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill. "We are fast compiling a robust and extensive safety data set with opaganib, giving us good reason to look forward to the rapid conclusion of this study which, if positive, is expected to provide the necessary efficacy data to support the next step of emergency use applications in the first quarter of 2020."

    Enrollment in the 270-patient global Phase 2/3 study with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) is more than 50% complete. The study, approved in six countries and rapidly enrolling across 22 study sites, is on track to deliver top line data in the first quarter of 2021. This study is focused on and powered for efficacy evaluation. A prescheduled, unblinded futility interim analysis will be conducted by the DSMB in the coming weeks, evaluating data from the first 135 subjects that have reached the primary endpoint.

    The parallel U.S. Phase 2 study with opaganib (NCT04414618) has completed enrollment of all 40 subjects, with topline data expected in the coming weeks. This study is not powered for efficacy and is focused on safety evaluation and identification of efficacy signals.

    Opaganib is a novel, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that acts on the cause and effect of COVID-19 disease, targeting a host cell component involved in viral replication, potentially minimizing likelihood of resistance due to viral mutations.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood for resistance due to viral mutations. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory and gastrointestinal indications.

    Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of severe COVID-19. Opaganib also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies[2] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    Under a compassionate use program, patients with severe COVID-19 (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published[3]. Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults with non-cancer pain[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the timing of the reporting of data from the U.S. Phase 2 trial evaluating opaganib, the timing of potential emergency use applications of opaganib and reporting of topline data, safety analysis and of unblinded futility interim analysis for the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be successful; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the reporting of data from this clinical study will be delayed if at all; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment, reporting of topline data, safety analysis and/or unblinded futility interim analysis will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

     

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [3] Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate Use of Opaganib For Patients with Severe COVID-19. medRxiv 2020.06.20.20099010; doi: https://doi.org/10.1101/2020.06.20.20099010

    [4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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    SOURCE RedHill Biopharma Ltd.

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  20. TEL AVIV, Israel and RALEIGH, N.C., Nov. 17, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for a Phase 2/3 study evaluating orally administered RHB-107 (upamostat)[1] in patients with symptomatic COVID-19 who do not require hospitalization.

    RedHill Biopharma Logo

    "This is a significant milestone in our efforts to combat the effects of the COVID-19 pandemic. The ability to treat patients earlier in the course of COVID-19 disease, using an oral therapy that enables treatment outside of a hospital setting, is of critical importance given the large proportion…

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 17, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for a Phase 2/3 study evaluating orally administered RHB-107 (upamostat)[1] in patients with symptomatic COVID-19 who do not require hospitalization.

    RedHill Biopharma Logo

    "This is a significant milestone in our efforts to combat the effects of the COVID-19 pandemic. The ability to treat patients earlier in the course of COVID-19 disease, using an oral therapy that enables treatment outside of a hospital setting, is of critical importance given the large proportion of patients that are not hospitalized but are still very much at risk of disease progression," said Terry F. Plasse MD, Medical Director at RedHill. "With RHB-107 and opaganib[2], RedHill has two novel, late-stage, oral therapeutic candidates with potential to reduce the impact of COVID-19 disease, both of which target host cell components, potentially minimizing the likelihood of resistance due to emergence of viral mutations."

    RHB-107 is a proprietary, first-in-class, orally administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects. This combined antiviral and potential tissue-protective action make it a promising candidate for evaluation as a treatment for COVID-19 disease. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial cell model and its safety profile has been demonstrated in approximately 200 people, including in Phase 2 studies in oncology indications. RedHill licensed RHB-107 (formerly Mesupron) from Heidelberg Pharma AG (FWB: HPHA, formerly Wilex AG).

    The randomized, parallel-group double-blind Phase 2/3 study is expected to start enrolling patients early next year. The study will enroll patients with symptomatic diagnostically confirmed COVID-19 who do not require inpatient care. RHB-107 will be administered once daily for 14 days, with patients receiving follow-up for eight weeks from first dosing. The primary endpoints will be time to recovery from symptomatic illness compared to placebo, as well as safety and tolerability of RHB-107. Several secondary and exploratory endpoints will also be assessed.

    The late-stage development program for RedHill's other COVID-19 candidate, opaganib, in patients with severe COVID-19 pneumonia includes: The U.S. Phase 2 study (NCT04414618) is now fully enrolled and expected to report topline data in the coming weeks; and the global Phase 2/3 study (NCT04467840) which is more than 50% enrolled and is on track to enroll up to 270 patients and report topline data in support of potential emergency use applications in the first quarter of 2021. Both studies are randomized, double-blind, parallel-arm, placebo-controlled trials with opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.

    About RHB-107 (upamostat)

    RHB-107 is a proprietary, first-in-class, orally administered potent inhibitor of several serine proteases, with demonstrated antiviral and potential tissue-protective effects. This combined antiviral and potential tissue-protective action make it a strong candidate for evaluation as a treatment for COVID-19 disease. In addition, RHB-107 has potential in targeting cancer, inflammatory lung diseases and gastrointestinal diseases, and has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (formerly WILEX AG) for all indications.

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults with non-cancer pain[3], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[4], and Aemcolo® for the treatment of travelers' diarrhea in adults[5]. RedHill's key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107 (upamostat), a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

     This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that enrollment in the company's Phase 2/3 study evaluating RHB-107 in patients with symptomatic COVID-19 will be delayed, the risk that the Company's Phase 2/3 development program evaluating opaganib will not be successful and that the data from this clinical study will be delayed, if at all; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the data from this clinical study will be delayed if at all; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

     

     

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

    [1] RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.

    [2] Opaganib is an investigational new drug, not available for commercial distribution

    [3] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [4] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [5] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharmas-second-covid-19-candidate-rhb-107-cleared-by-fda-for-phase-23-study-in-symptomatic-covid-19-disease-301174585.html

    SOURCE RedHill Biopharma Ltd.

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  21. TEL AVIV, Israel and RALEIGH, NC, Nov. 16, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Phase 2 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has completed enrollment of the last patient in the study. The study is not powered for statistical significance. Topline data is expected in the coming weeks.

     

    RedHill Biopharma Logo

     

    "Completing enrollment in this U.S. Phase 2 study of orally administered opaganib in severe COVID-19 is a key milestone, indicating that we are just weeks away from important safety data and increased understanding of the potential of opaganib. In parallel, our global Phase 2/3…

    TEL AVIV, Israel and RALEIGH, NC, Nov. 16, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Phase 2 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has completed enrollment of the last patient in the study. The study is not powered for statistical significance. Topline data is expected in the coming weeks.

     

    RedHill Biopharma Logo

     

    "Completing enrollment in this U.S. Phase 2 study of orally administered opaganib in severe COVID-19 is a key milestone, indicating that we are just weeks away from important safety data and increased understanding of the potential of opaganib. In parallel, our global Phase 2/3 study is approximately 50% enrolled and is expected to undergo its first pre-planned safety analysis in the coming days and report topline data in the first quarter of 2021. We are compiling a robust data set to support the planned emergency use applications, expected as early as next quarter, subject to study success." said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. "Opaganib has a demonstrated unique dual mode of action that is both anti-inflammatory and antiviral – acting on the cause and the effect of COVID-19. Moreover, opaganib acts on a host cell component involved in viral replication and not the virus itself, which could minimize issues of resistance due to emergence of viral mutations. In light of the encouraging data from patients with severe COVID-19 treated with opaganib under compassionate use[2] and the potent anti-SARS-CoV-2 activity that opaganib has demonstrated in vitro, we are excited to see the data from the U.S. Phase 2 study and look to rapidly complete the global Phase 2/3 development program for opaganib toward potential emergency use authorization applications."

    The randomized, double-blind, placebo-controlled Phase 2 study with opaganib (NCT04414618) enrolled 40 patients in clinical sites across the U.S. The study is not powered for statistical significance and is focused on safety evaluation and identifying a signal of efficacy. Patients in the study were randomized at a 1:1 ratio to receive either opaganib or placebo on top of standard-of-care. The primary objective of the study is to evaluate the reduction in total oxygen requirement over the course of treatment for up to 14 days. Secondary endpoints include time to 50% reduction in oxygen requirements, the proportion of patients without fever at Day 14, and proportion with negative nasal swabs at Day 14.

    In parallel, the global Phase 2/3 study with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) is approximately 50% enrolled and is expected to report topline data in the first quarter of 2021. The study is being conducted across 21 clinical sites and is on track to enroll up to 270 patients. A first unblinded review of safety data from the first 70 patients enrolled in the study by an independent Data and Safety Monitoring Board (DSMB) is expected in the coming days. An unblinded futility interim analysis will be conducted by the DSMB in the coming weeks, evaluating data from the first 135 subjects that have reached the primary endpoint. This study is focused on, and powered for, efficacy evaluation. The study has been approved in the UK, Italy, Russia, Mexico, Brazil and Israel, with further expansion ongoing. 

    The clinical studies with opaganib are intended to support potential emergency use applications as early as the first quarter of 2021, subject to positive results. 

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component of viral replication, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of COVID-19.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies[3] have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    Under a compassionate use program, COVID-19 patients (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published[2]. Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group. 

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma    

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults with non-cancer pain[4], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], and Aemcolo® for the treatment of travelers' diarrhea in adults[6]. RedHill's key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and includes statements regarding the timing of the reporting of data from the U.S. Phase 2 trial evaluating opaganib, the timing of potential emergency use applications of opaganib. Reporting of topline data, safety analysis and of unblinded futility interim analysis for the global Phase 2/3 study with opaganib. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be successful; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that the reporting of data from this clinical study will be delayed if at all; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment, reporting of topline data, safety analysis and/or unblinded futility interim analysis will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    References:

    [1] Opaganib is an investigational new drug, not available for commercial distribution.

    [2] Kurd R, Ben-Chetrit E, Karameh H, Bar-Meir M, Compassionate Use of Opaganib For Patients with Severe COVID-19. medRxiv 2020.06.20.20099010; doi: https://doi.org/10.1101/2020.06.20.20099010

    [3] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    [4] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    [5] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    [6] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Logo - /files/images/story/2020/fileA4YArz

     

     

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

     

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

     

     

    Cision View original content:http://www.prnewswire.com/news-releases/redhill-biopharma-completes-enrollment-for-covid-19-us-phase-2-study-with-opaganib--data-expected-in-the-coming-weeks-301173725.html

    SOURCE RedHill Biopharma Ltd.

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  22. TEL AVIV, Israel and RALEIGH, N.C., Nov. 13, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Guy Goldberg, RedHill's Chief Business Officer, will present a corporate overview and host 1-on-1 investor meetings at the German Equity Forum (Deutsches Eigenkapital Forum) 2020, one of Europe's largest investor events, on Tuesday, November 17, 2020, at 9:30 a.m. CET.

    The presentation will be available via replay for 30 days on the Company's website: https://ir.redhillbio.com.

    About RedHill Biopharma           
    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious…

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 13, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Guy Goldberg, RedHill's Chief Business Officer, will present a corporate overview and host 1-on-1 investor meetings at the German Equity Forum (Deutsches Eigenkapital Forum) 2020, one of Europe's largest investor events, on Tuesday, November 17, 2020, at 9:30 a.m. CET.

    The presentation will be available via replay for 30 days on the Company's website: https://ir.redhillbio.com.

    About RedHill Biopharma           

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Movantik® for opioid-induced constipation in adults1, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults2, and Aemcolo® for the treatment of travelers' diarrhea in adults3. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibb

    Vice President

    Finn Partners

    +1 212 529 2236

    _____________

    1
    Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    2 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    3 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.



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  23. Q3/2020 net revenues of approximately $21 million, with gross profit of $10.6 million, or approximately 51%, up from $6.7 million and approximately 32% in Q2/2020
    --
    Strong growth for Talicia®with approximately 300% quarter-over-quarter prescription growth and rapid expansion of the prescriber base; Talicia achieved national coverage for 167 million lives since launch, with additional coverage expected
    --
    Two consecutive quarters of Movantik® prescription (TRx) growth, reversing the trend of prescription decline prior to RedHill acquisition
    --
    Opaganib's COVID-19 global Phase 2/3 study advancing rapidly with nearly 50% of patients enrolled and U.S. Phase 2 study over 90% enrolled; Initiated manufacturing ramp-up in preparation for potential emergency

    Q3/2020 net revenues of approximately $21 million, with gross profit of $10.6 million, or approximately 51%, up from $6.7 million and approximately 32% in Q2/2020

    --

    Strong growth for Talicia® with approximately 300% quarter-over-quarter prescription growth and rapid expansion of the prescriber base; Talicia achieved national coverage for 167 million lives since launch, with additional coverage expected

    --

    Two consecutive quarters of Movantik® prescription (TRx) growth, reversing the trend of prescription decline prior to RedHill acquisition

    --

    Opaganib's COVID-19 global Phase 2/3 study advancing rapidly with nearly 50% of patients enrolled and U.S. Phase 2 study over 90% enrolled; Initiated manufacturing ramp-up in preparation for potential emergency use applications as early as Q1/2021

    --

    Commencing Phase 3 study with RHB-204 for first-line treatment of pulmonary NTM infections

    --

    Cash balance of approximately $51 million as of September 30, 2020

    --

    Management to host webcast today, at 8:30 a.m. EST

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 12, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the third quarter ended September 30, 2020.

    Dror Ben-Asher, RedHill's Chief Executive Officer, said: "Despite the challenging pandemic environment, we have shown the strength of our commercial organization. Our extensive promotional efforts for Talicia delivered 300% quarter-over-quarter prescription growth, as well as rapid expansion of the prescriber base alongside national payor coverage for 167 million Americans. Movantik prescriptions grew for a second consecutive quarter - reversing the trend of prescription decline prior to its acquisition by RedHill." Mr. Ben-Asher continued: "Our global Phase 2/3 and U.S. Phase 2 studies with opaganib for COVID-19 are quickly approaching completion and are supplemented by data demonstrating opaganib's complete inhibition of SARS-CoV-2 viral replication. We have also initiated manufacturing ramp-up in preparation for potential emergency use applications for opaganib in the first quarter of 2021. We are initiating the Phase 3 study of RHB-204 as an oral first-line therapy for pulmonary NTM infections, a disease with a significant unmet need and no FDA-approved first-line treatment."

    Micha Ben Chorin, Chief Financial Officer at RedHill, added: "This has been another positive quarter for the Company. We have significantly increased gross profit from 32% in the second quarter to 51% thanks to our new agreement with Daiichi Sankyo Inc. We expect the trend of increasing Movantik prescriptions to continue. We are pleased with the successful transition of Movantik from AstraZeneca and expect savings in operating expenses, as well as higher distribution service agreement fees to apply. We continue to effectively manage our cash position and continue to work toward operational break-even next year."

    Financial highlights for the third quarter ended September 30, 20201

    Net Revenues of $20.9 million, continuing at a similar level to that in the second quarter of 2020. The increase in gross revenues, as well as in the number of scripts for Talicia and Movantik, were partially offset by the voluntary discontinuation of our legacy products.

    Cost of Revenues of $10.3 million, compared to $14.2 million in the second quarter of 2020. The decrease was attributable to the reduced royalty rate payable to Daiichi Sankyo, Inc. for Movantik following the new agreement between the companies.

    Gross Profit of $10.6 million, compared to $6.7 million in the second quarter of 2020. Gross profit of 51%, up from 32% in the second quarter, is attributable to the lower royalties payable.

    Research and Development Expenses were $4.3 million, compared to $3.2 million in the second quarter of 2020. The increase was primarily attributable to the progression of the opaganib COVID-19 studies and to initiation activities for the Phase 3 study with RHB-204 for NTM infections.

    Selling, Marketing and Business Development Expenses were $13.4 million, compared to $10 million in the second quarter of 2020. The increase was primarily attributable to the expansion of commercialization activities related to Talicia and Movantik, as well as to the payment received in the second quarter under the U.S. Small Business Administration Payroll Protection Program (PPP) which was recorded as a reduction in expenses.

    General and Administrative Expenses were $7.3 million, compared to $6 million in the second quarter of 2020. The increase was primarily attributable to the payment received in the second quarter under the PPP which was recorded as a reduction from expenses.

    Operating Loss was $14.5 million, compared to $12.5 million in the second quarter of 2020. The increase was primarily attributable to the expansion of commercialization activities related to Talicia and Movantik and investment in the studies with opaganib and RHB-204, partially offset by the increase in gross profit, as described above.

    Net Loss was $18.6 million, compared to $16 million in the second quarter of 2020. The increase was primarily attributable to the increase in operating loss, as detailed above, and the increase in financing expenses due to the financial liability related to the new agreement with Daiichi Sankyo.

    Net Cash Used in Operating Activities was $9.2 million, compared to $15 million in the second quarter of 2020. The decrease was primarily attributable to positive changes in working capital.

    Net Cash Provided by Financing Activities was $12 million, compared to $5.5 million in the second quarter of 2020. The increase was primarily attributable to the increase in proceeds from the Company's "at-the-market" (ATM) facility and a reduction in restricted cash.

    Liquidity and Capital Resources

    Cash Balance2 as of September 30, 2020, was $50.9 million, compared to $53.1 million as of June 30, 2020. The decrease was primarily attributable to the net cash used in operating activities, as detailed above, partially offset by proceeds of $9.1 million from the Company's ATM in the third quarter of 2020.

    Subsequent to September 30, 2020, and through November 11, 2020, 240,614 American Depositary Shares (ADSs) of the Company were issued under the Company's ATM facility, generating additional net proceeds of approximately $2.3 million.

    Commercial Highlights:

    Movantik® (naloxegol)3

    The Company has completed the transition of Movantik from AstraZeneca and achieved two consecutive full quarters of RedHill-led prescription. Additionally, the Company has targeted a larger prescriber base that has driven a 2.1% increase in unique prescribers of Movantik. This growth reverses a steady decline in prescriptions prior to RedHill acquiring the rights to Movantik, representing a shift in the trend and pointing to both a successful transition by RedHill and the prospects for continuing growth for Movantik.

    RedHill acquired the global rights to Movantik from AstraZeneca, excluding Europe and Canada, and has, this quarter, replaced a co-commercialization agreement with Daiichi Sankyo (assigned under the agreement with AstraZeneca), with a new royalty-bearing agreement that resulted in RedHill assuming full control over brand strategy and commercialization activities for Movantik in the U.S. and increasing gross margin.

    Talicia® (omeprazole magnesium, amoxicillin and rifabutin)4

    Since RedHill launched Talicia in the U.S. in March 2020, the Company has focused its efforts on the groundwork needed for ongoing and rapid growth, including expansion of the prescriber base. This has resulted in a 300% quarter-on-quarter increase in Talicia prescriptions. This growth is supported by major additions of Talicia as a preferred brand on leading national formularies - achieving coverage for 167 million lives in the commercial and governmental segments. Further formulary additions are expected in the near future, in addition to the previously announced listings of Talicia on the national formularies of Prime Therapeutics, EnvisionRx, and Express Scripts.

    R&D Highlights



    COVID-19 (SARS-CoV-2) Program: Opaganib (ABC294640, Yeliva®)5

    Following encouraging compassionate use results published6 last quarter, the late-stage development program for opaganib in patients with severe COVID-19 pneumonia has progressed rapidly. The Company is currently enrolling patients in two randomized, double-blind, parallel-arm, placebo-controlled studies with opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen:

    • Enrollment in the U.S. Phase 2 study (NCT04414618) is over 90% complete and top-line data is expected before the end of this year, subject to recruitment completion. The study has passed two pre-scheduled safety reviews by an independent Safety Monitoring Committee (SMC) with unanimous recommendations to continue the study without change.



    • A global Phase 2/3 study (NCT04467840) is advancing rapidly and is approaching 50% enrollment. Approved in six countries and active across 20 clinical sites to date, the study is on track to enroll up to 270 patients.



    • The studies are intended to support potential emergency use applications as early as the first quarter of 2021, subject to positive results.

    On September 8, 2020, RedHill announced that opaganib demonstrated potent inhibition of SARS-CoV-2, achieving complete blockage of viral replication, as measured after three days incubation, in an in vitro model of human bronchial tissue, comparing favorably with remdesivir, the positive control in the study. Furthermore, treatment of cells infected with SARS-CoV-2 with opaganib did not compromise cell membrane integrity, a measure of cell viability and drug safety, further demonstrating opaganib's promising potential for treating patients with COVID-19.

    The Company also entered into collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing in preparation for potential emergency use authorizations, further strengthening manufacturing capabilities and capacity for opaganib. RedHill continues to expand manufacturing capacity with additional supply agreements expected to be finalized in the coming weeks.

    The Company continues its discussions with U.S. and other government agencies and non-governmental organizations around potential funding to support the rapid advancement of opaganib toward potential emergency use applications and manufacturing scale-up. In September 2020, opaganib was awarded a grant from Pennsylvania's COVID-19 Vaccines, Treatments and Therapies Program, which supports the rapid advancement of promising novel COVID-19 therapies.

       

    COVID-19 (SARS-CoV-2) Program: RHB-107 (upamostat)7

    In recently released in vitro results, RedHill's second COVID-19 drug candidate, RHB-107, a novel, orally-administered serine protease inhibitor, strongly inhibited SARS-CoV-2 viral replication. The Company has submitted an Investigational New Drug (IND) application to the FDA for a U.S. Phase 2/3 study with RHB-107 in moderate COVID-19 patients treated in an outpatient setting, a different population to opaganib which is being evaluated in hospitalized patients with severe COVID-19 disease. The study is planned to be initiated early in 2021.

    RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Infections

    RedHill announced in July 2020 that the U.S. FDA had cleared its IND application for a Phase 3 study to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium Complex (MAC) infection. RedHill is currently initiating the Phase 3 study of RHB-204 in the U.S. The study aims to enroll 125 patients in up to 40 sites across the U.S.

    The Company recently announced that RHB-204 had been granted FDA Orphan Drug Designation. This, along with RHB-204's previously granted QIDP designation, extends U.S. market exclusivity for RHB-204 to a potential total of 12 years upon FDA approval.

    Opaganib - Cholangiocarcinoma and prostate cancer

    The Phase 2a study evaluating the activity of opaganib in advanced cholangiocarcinoma (bile duct cancer) is ongoing. Enrollment has been completed for the first cohort of 39 patients, evaluating the activity of orally-administered opaganib as a stand-alone treatment. Preliminary data from this cohort indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma, and in light of these data, input from key opinion leaders and preclinical research that had been conducted at Mayo Clinic, RedHill initiated enrollment for a second cohort, evaluating opaganib in combination with hydroxychloroquine, an anti-autophagy agent.

    In light of preclinical findings demonstrating that treatment with opaganib and RHB-107 (upamostat, WX-671) in combination resulted in tumor regression, RedHill plans to add an additional cohort to the ongoing Phase 2a study, evaluating opaganib in combination with RHB-107, subject to discussions with the FDA.

    RedHill recently announced that it had received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent application related to the use of opaganib and RHB-107 for the treatment of solid tumor cancers. The patent is expected to extend IP protection for the combination until 2036.

    An additional Phase 2 study with opaganib in prostate cancer is ongoing at the Medical University of South Carolina (MUSC). The study is supported by a National Cancer Institute grant awarded to MUSC with additional support from RedHill.

    Exclusive Licensing and Manufacturing Agreement with Cosmo Pharmaceuticals

    RedHill announced in August 2020 that it had entered into a binding term sheet with Cosmo Pharmaceuticals N.V. (SIX: COPN) (Cosmo) for an exclusive licensing and manufacturing agreement for multiple products.

    COVID-19 Impact Update

    RedHill's primary concern during the COVID-19 pandemic continues to be the safety and protection of its employees, patients, colleagues, and the communities to which we belong.

    Operationally, the actions the Company took to mitigate the impact of the COVID-19 pandemic continue to serve us well, with minimal effect on our ongoing operational and supply chain activities. Promotional activity has now been largely re-instated where safe to do so, and in adherence to social distancing and other public health guidelines. RedHill will continue to assess the potential impact of COVID-19 on its business and operations.

    Conference Call and Webcast Information:

    The Company will host a conference call and live webcast today, Thursday, November 12, 2020, at 8:30 a.m. EST to present the third quarter financial results and operational highlights.

    The webcast and accompanying slides will be broadcast live on the Company's website: http://ir.redhillbio.com/events and will be available for replay for 30 days.

    To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel: +972-3-530-8845; the access code for the call is: 4549918.

    About RedHill Biopharma           

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults8, Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults9, and Aemcolo® for the treatment of travelers' diarrhea in adults10. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation; the risk of a delay in the closing of the exclusive licensing and manufacturing agreement with Cosmo, the risk that the transaction with Cosmo will close on different terms than the terms of the binding term sheet, if it will close at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk of delay in the completion of the enrollment for this study; the risk that the Company will not expand the Phase 2/3 study to additional countries; the risk of a delay in the date that the Phase 2 study and Phase 2/3 study will deliver data for emergency use applications, if at all; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under the compassionate use programs; the risk of a delay in the enrollment of the Phase 3 study with RHB-204 and that the study will not be successful; the risk of delay in initiation of the U.S. Phase 2/3 study with RHB-107 in patients with moderate COVID-19 treated in an outpatient setting; the risk that the Company will not succeed to show operational break-even next year, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and continued employment of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.



    REDHILL BIOPHARMA LTD.

    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

    (Unaudited)

              
      Three Months Ended   Nine Months Ended
      September 30,   September 30, 
       2020 2019   2020 2019 
       
      U.S. dollars in thousands
    NET REVENUES  20,943  1,401    42,898  4,701 
    COST OF REVENUES  10,337  629    26,240  1,471 
    GROSS PROFIT   10,606  772    16,658  3,230 
    RESEARCH AND DEVELOPMENT EXPENSES, net  4,323  2,799    10,302  15,143 
    SELLING, MARKETING AND BUSINESS DEVELOPMENT EXPENSES  13,414  4,892    32,384  12,175 
    GENERAL AND ADMINISTRATIVE EXPENSES  7,329  2,925    17,948  7,349 
    OPERATING LOSS  14,460  9,844    43,976  31,437 
    FINANCIAL INCOME   42  170    339  1,075 
    FINANCIAL EXPENSES  4,220  161    8,205  251 
    FINANCIAL EXPENSES (INCOME), net  4,178  (9)   7,866  (824)
    LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD  18,638  9,835    51,842  30,613 
              
    LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars):  0.05  0.03    0.14  0.11 
    WEIGHTED AVERAGE OF ORDINARY SHARES (in thousands)  372,893  283,687    359,428  283,687 



    REDHILL BIOPHARMA LTD.


    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION           

          
       September 30,  December 31, 
          2020     2019 
        
       Unaudited                 Audited
        U.S. dollars in thousands
    CURRENT ASSETS:     
    Cash and cash equivalents   26,198   29,023 
    Bank deposits   6,187   10,349 
    Financial assets at fair value through profit or loss   2,407   8,500 
    Trade receivables   12,424   1,216 
    Prepaid expenses and other receivables   4,635   2,244 
    Inventory   5,100   1,882 
        56,951   53,214 
    NON-CURRENT ASSETS:     
    Restricted cash   16,153   152 
    Fixed assets   473   228 
    Right-of-use assets   5,448   3,578 
    Intangible assets   89,956   16,927 
        112,030   20,885 
    TOTAL ASSETS   168,981   74,099 
          
          
    CURRENT LIABILITIES:       
    Accounts payable   6,569   4,184 
    Lease liabilities   1,546   834 
    Accrued expenses and other current liabilities   23,536   5,598 
        31,651   10,616 
          
    NON-CURRENT LIABILITIES:     
    Borrowing   80,266   — 
    Payable in respect of intangible assets purchase   23,739   — 
    Lease liabilities   4,079   2,981 
    Royalty obligation   500   500 
        108,584   3,481 
    TOTAL LIABILITIES   140,235   14,097 
          
          
    EQUITY:     
    Ordinary shares   1,025   962 
    Additional paid-in capital   284,806   267,403 
    Accumulated deficit   (257,085)  (208,363)
    TOTAL EQUITY   28,746   60,002 
          
    TOTAL LIABILITIES AND EQUITY   168,981   74,099 



    REDHILL BIOPHARMA LTD.


    CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

    (Unaudited)

             
      Three Months Ended  Nine Months Ended
      September 30,  September 30, 
       2020     2019  2020     2019 
       
      U.S. dollars in thousands
    OPERATING ACTIVITIES:        
    Comprehensive loss  (18,638)  (9,835)  (51,842)  (30,613)
    Adjustments in respect of income and expenses not involving cash flow:        
    Share-based compensation to employees and service providers  1,695   782   3,120   2,278 
    Depreciation  470   288   1,237   744 
    Amortization and impairment of intangible assets  2,109   —   4,958   — 
    Unpaid interest expenses related to borrowing and payable in respect of intangible assets purchase  2,039   —   3,656   — 
    Fair value adjustments on derivative financial instruments  —   (5)  —   (336)
    Fair value losses (gains) on financial assets at fair value through profit or loss  31   14   68   (73)
    Exchange differences and revaluation of bank deposits  5   180   (160)  112 
       6,349   1,259   12,879   2,725 
    Changes in assets and liability items:        
    Decrease (increase) in trade receivables  6,146   110   (11,208)  105 
    Decrease (increase) in prepaid expenses and other receivables  235   (23)  (2,391)  (462)
    Increase in inventories  (350)  (135)  (3,218)  (1,192)
    Increase (decrease) in accounts payable  1,261   51   2,385   1,470 
    Increase (decrease) in accrued expenses and other current liabilities  (4,174)  (321)  17,521   1,087 
       3,118   (318)  3,089   1,008 
    Net cash used in operating activities  (9,171)  (8,894)  (35,874)  (26,880)
    INVESTING ACTIVITIES:         
    Purchase of fixed assets  (166)  (1)  (357)  (135)
    Purchase of intangible assets  (735)  —   (53,368)  — 
    Change in investment in current bank deposits  —   6,000   4,200   4,931 
    Purchase of financial assets at fair value through profit or loss  —   (9)  —   (2,584)
    Proceeds from sale of financial assets at fair value through profit or loss  2,075   5,748   6,025   7,848 
    Net cash provided by (used in) investing activities  1,174   11,738   (43,500)  10,060 
    FINANCING ACTIVITIES:        
    Proceeds from issuance of ordinary shares, net of issuance costs  9,137   —   15,500   — 
    Exercise of options into ordinary shares  53   —   53   — 
    Proceeds from long-term borrowings, net of transaction costs  (784)  —   78,061   — 
    Increase in restricted cash  —   —   (20,000)  — 
    Decrease in restricted cash  4,000     4,000   
    Payment of principal with respect to lease liabilities  (450)  (206)  (1,186)  (591)
    Net cash provided by (used in) financing activities  11,956   (206)  76,428   (591)
     INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS  3,959   2,638   (2,946)  (17,411)
    EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS  (33)  1   121   40 
    BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD  22,272   8,995   29,023   29,005 
    BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD  26,198   11,634   26,198   11,634 
    SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH  71   284   320   609 
    SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH  2,147   48   4,507   71 
    SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:        
    Acquisition of right-of-use assets by means of lease liabilities  533   —   2,738   2,681 
    Purchase of intangible assets posted as payable  12,511   —   24,619   — 
    Purchase of an intangible asset in consideration for issuance of shares  1,914   —   1,914   — 

    ____________________________

    1All financial highlights are approximate and are rounded to the nearest hundreds of thousands.

    2Including cash, short-term investments (bank deposits and financial assets at fair value) and restricted cash.

    3Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.

    4Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.

    5Opaganib (ABC294640, Yeliva®) is an investigational new drug, not available for commercial distribution.

    6The article was authored by Ramzi Kurd, MD, Shaare-Zedek Medical Center; Eli Ben-Chetrit, MD, Shaare-Zedek Medical Center and Hebrew University Faculty of Medicine; Hani Karameh MD, Shaare-Zedek Medical Center and Maskit Bar-Meir, MD, Shaare-Zedek Medical Center and Hebrew University Faculty of Medicine. See full text here: https://www.medrxiv.org/content/10.1101/2020.06.20.20099010v1?rss=1.

    7RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.

    8Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

    9Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    10Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

     

    Company contact:
    Adi Frish
    Chief Corporate and Business Development Officer
    RedHill Biopharma
    +972-54-6543-112
    
    
    Media contact (U.S.):
    Bryan Gibbs
    Vice President
    Finn Partners
    +1 212 529 2236
    
    

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  24. TEL AVIV, Israel and RALEIGH, N.C., Nov. 05, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its third-quarter 2020 financial results and business highlights on Thursday, November 12, 2020.

    The Company will host a conference call and webcast on Thursday, November 12, 2020, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2020, including:

    • Financial performance for the quarter ended September 30, 2020;
    • Commercial activities status;
    • The progress of the late-stage development program with opaganib for COVID-19 and preparation for potential emergency use applications;
    • Pipeline progress…

    TEL AVIV, Israel and RALEIGH, N.C., Nov. 05, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its third-quarter 2020 financial results and business highlights on Thursday, November 12, 2020.

    The Company will host a conference call and webcast on Thursday, November 12, 2020, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2020, including:

    • Financial performance for the quarter ended September 30, 2020;
    • Commercial activities status;
    • The progress of the late-stage development program with opaganib for COVID-19 and preparation for potential emergency use applications;
    • Pipeline progress, including the granting of Orphan Drug Designation and the Phase 3 study with RHB-204 for first-line pulmonary nontuberculous mycobacteria (NTM) infections.

    The webcast and slides will be broadcasted live on the Company's website: http://ir.redhillbio.com/events and available for replay for 30 days.

    To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel: +972-3-530-8845; the access code for the call is: 4549918.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults1, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults2, and Aemcolo® for the treatment of travelers' diarrhea in adults3. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    _________________________________________________

    1 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    2 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    3 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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  25. Notice of Allowance received for combination of RedHill's novel orally-administered investigational drugs, opaganib and RHB-107, for treatment of solid tumor cancers; patent expected to extend IP protection until 2036

    --

    Combination of opaganib and RHB-107 demonstrated potent antitumor effect and tumor regression in recent cholangiocarcinoma pre-clinical study

     --

    RedHill plans to add third cohort evaluating this combination to its ongoing Phase 2a study of opaganib in advanced cholangiocarcinoma, subject to FDA discussions


    TEL AVIV, Israel and RALEIGH, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced…

    Notice of Allowance received for combination of RedHill's novel orally-administered investigational drugs, opaganib and RHB-107, for treatment of solid tumor cancers; patent expected to extend IP protection until 2036

    --

    Combination of opaganib and RHB-107 demonstrated potent antitumor effect and tumor regression in recent cholangiocarcinoma pre-clinical study

     --

    RedHill plans to add third cohort evaluating this combination to its ongoing Phase 2a study of opaganib in advanced cholangiocarcinoma, subject to FDA discussions



    TEL AVIV, Israel and RALEIGH, N.C., Nov. 04, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent application related to the use of two of RedHill's proprietary investigational compounds, opaganib (Yeliva®, ABC294640) and RHB-107 (upamostat)1, for the treatment of solid tumor cancers. The patent is expected to extend IP protection for the combination until 2036.

    Findings from a recent pre-clinical study evaluating the antitumor effect of opaganib and RHB-107 on cholangiocarcinoma (also known as bile duct cancer) patient-derived xenografts demonstrated that treatment with opaganib and RHB-107, individually and in combination, resulted in tumor regression. Moreover, the combination of both drugs was found to be more potent and well tolerated in the animal models. These findings were presented at the American Association for Cancer Research (AACR) annual meeting earlier this year2.

    "It is becoming increasingly evident that cancers are dependent on a number of altered molecular pathways and can develop diverse mechanisms of resistance to therapy with single agents," said Danielle T. Abramson, Ph.D., VP, Intellectual Property & Research at RedHill. "This application is part of a growing patent portfolio that expands patent protection for our oncology program through 2036. We are very pleased with the additional IP protection for the novel combination of opaganib and RHB-107, which follows promising findings on the potent synergistic antitumor activity of this combination."

    RedHill is conducting a Phase 2a study evaluating the activity of opaganib in advanced, unresectable intrahepatic, perihilar and extrahepatic cholangiocarcinoma (NCT03377179). Enrollment has been completed for the first cohort of 39 patients, evaluating the activity of orally-administered opaganib as a stand-alone treatment. Preliminary data from this cohort indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma, and in light of these data, input from key opinion leaders and preclinical research that had been conducted at Mayo Clinic, RedHill initiated enrollment for a second cohort, evaluating opaganib in combination with hydroxychloroquine, an anti-autophagy agent. Given the encouraging pre-clinical data, RedHill plans to add an additional cohort to the ongoing Phase 2a study in cholangiocarcinoma, evaluating opaganib in combination with RHB-107, subject to discussions with the U.S. FDA.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of severe COVID-19.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies3 have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    Under a compassionate use program, patients with COVID-19 (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published2. Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

    About RHB-107 (upamostat)

    RHB-107 is a proprietary, first-in-class, orally-administered potent inhibitor of several serine proteases with demonstrated antiviral and potential tissue-protective effects. This combined antiviral and potential tissue-protective action make RHB-107 a strong candidate for evaluation as a treatment for COVID-19. A U.S. Phase 2/3 study with RHB-107 in an outpatient setting is planned to be initiated later this year. In addition, RHB-107 has potential in targeting cancer, inflammatory lung diseases and gastrointestinal diseases, and has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in over 300 patients. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharmaceuticals (formerly WILEX AG) for all indications.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults with non-cancer pain4, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults5, and Aemcolo® for the treatment of travelers' diarrhea in adults6. RedHill's key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.



    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties, include without limitation, the risk that the Company will not succeed in adding a third cohort to its ongoing Phase 2a clinical study in patients suffering from advanced cholangiocarcinoma, in which the Company expects to evaluate the efficacy of opaganib in combination with RHB-107; as well as other risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and commercial products; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and maintaining employment of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibbs

    Vice President

    Finn Partners

    +1 212 529 2236

    ________________________

    1 Opaganib (Yeliva®, ABC294640) and RHB-107 (upamostat, WX-671) are investigational new drugs, not available for commercial distribution.

    2 Faizal ZA et al. Abstract 3078: Effects of upamostat and opaganib on cholangiocarcinoma patient derived xenografts. Cancer Res August 15 2020 (80) (16 Supplement) 3078; DOI: 10.1158/1538-7445.AM2020-3078

    3 Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    4 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    5 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    6 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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  26.  H. pylori eradication rates with clarithromycin-based triple therapy were found to be predictably low in the Phase 3 trial, with antibiotic resistance a contributing factor. Despite declining efficacy, physicians are still prescribing these regimens counter to ACG guidelines, which advocate for using first-line regimens that provide the highest likelihood of eradication success
    --
    Talicia's efficacy in the Phase 3 study was unaffected by patient body mass index (BMI), while published data suggest that BMI may be associated with the failure of clarithromycin-based H. pylori treatments, further supporting the use of Talicia as a first-line therapy in all populations
    --
    Talicia is the first and only FDA-approved rifabutin-based therapy for the treatment

     H. pylori eradication rates with clarithromycin-based triple therapy were found to be predictably low in the Phase 3 trial, with antibiotic resistance a contributing factor. Despite declining efficacy, physicians are still prescribing these regimens counter to ACG guidelines, which advocate for using first-line regimens that provide the highest likelihood of eradication success

    --

    Talicia's efficacy in the Phase 3 study was unaffected by patient body mass index (BMI), while published data suggest that BMI may be associated with the failure of clarithromycin-based H. pylori treatments, further supporting the use of Talicia as a first-line therapy in all populations

    --

    Talicia is the first and only FDA-approved rifabutin-based therapy for the treatment of H. pylori infection, designed as a first-line option to address the high and growing resistance of H. pylori to commonly used antibiotics

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 26, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that new data supporting the use of Talicia®1 as a first-line therapy for eradication of H. pylori in adults was presented at the American College of Gastroenterology (ACG) 2020 Virtual Annual Scientific Meeting. The Company also presented data highlighting the emerging patterns of H. pylori resistance to antibiotics used in current standard-of-care therapies.

    A key objective of the new U.S. Government "National Action Plan for Combating Antibiotic-Resistant Bacteria, 2020-2025"2 is lowering the annual rate of inappropriate outpatient antibiotic prescribing. Efficacy of treatments for H. pylori, one of the most prevalent infections in the U.S. and the leading cause of gastric cancer, has been steadily declining due to increasing levels of antibiotic resistance3. In tackling this problem, it is important to ensure successful first-line eradication of H. pylori infection. The analyses presented by RedHill at the ACG annual meeting aim to provide insights that may help avoid the risk of antibiotic resistance in the eradication of H. pylori.

    Poster 1: Persistent H. pylori infection following participation in two randomized controlled trials: Outcomes of patients receiving physician-directed standard-of-care therapy4.

    This analysis of data from the Talicia Phase 3 studies looked at the cure rates of physician-directed standard-of-care therapy for persistent H. pylori infection. The analysis found that eradication rates with empiric clarithromycin-based triple therapy were predictably low, and that despite declining efficacy of clarithromycin-containing therapies, physicians are still prescribing these regimens.

    "Despite the ACG treatment guideline recommendations for avoiding clarithromycin-containing triple therapy in patients with prior macrolide use and as salvage treatment, as well as other recommended restrictions based on resistance, clarithromycin-based therapies unfortunately remain an all too often prescribed treatment for H. pylori," said Dr. Colin W. Howden, MD, AGAF, FACG, Hyman Professor of Medicine & Chief of the Division of Gastroenterology, University of Tennessee Health Science Center. "Because H. pylori treatment is largely empiric, it is important that physicians prescribe a first-line regimen with the highest probability of successful eradication. A treatment regimen that does not contain clarithromycin, such as low dose rifabutin-based therapy, is a good first-line option to consider for H. pylori eradication." 

    Poster 2: Efficacy of H. pylori eradication by low-dose rifabutin triple therapy (RHB-105) is unaffected by BMI: Post-hoc analysis from two Phase 3 trials5.

    Winner of the ACG "Outstanding Poster Presenter" Award.

    With rising rates of obesity in the U.S., and published data suggesting that Body Mass Index (BMI) may be associated with the failure of clarithromycin-based H. pylori treatments6, it is imperative to study the influence of patient BMI on treatment success. This post-hoc analysis assessed the impact of BMI on eradication rates of H. pylori in patients with a BMI of both above and below 40, with results demonstrating that eradication rates with Talicia remained within the same high range, irrespective of patient BMI status. This maintenance of Talicia efficacy compares to an almost 50% reduction of eradication rates in amoxicillin/omeprazole-comparator-treated patients with BMI ≥40.

    "Antibiotic treatment failure in obese populations with H. pylori is a significant concern and may be linked to elevations in BMI," said Dr. June Almenoff, MD, Ph.D., RedHill's Chief Scientific Officer. "Given the trends of increasing BMI and growing antibiotic resistance in the U.S., it is critical to work towards first-line H. pylori eradication success in all patients irrespective of BMI. These data demonstrate that Talicia's efficacy rates were similarly high across patient sub-groups by BMI."

    About Talicia (omeprazole magnesium, amoxicillin and rifabutin)

    Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to commonly used clarithromycin-based therapies. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapy and are a strong public health concern, as highlighted by the FDA and the World Health Organization (WHO) in recent years.



    Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent7 to their therapy had eradication rates of 90.3% in the Talicia arm vs. 64.7% in the active comparator arm8.



    Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.



    About H. pylori

    H. pylori is a bacterial infection that affects approximately 35%9 of the U.S. population, with an estimated two million patients treated annually10. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer11 and a major risk factor for peptic ulcer disease12 and gastric mucosa-associated lymphoid tissue (MALT) lymphoma13. More than 27,000 Americans are diagnosed with gastric cancer annually14. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics commonly used in standard combination therapies15.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults with non-cancer pain16, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults17, and Aemcolo® for the treatment of travelers' diarrhea in adults18. RedHill's key clinical late-stage investigational development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.



    TALICIA: INDICATION AND USAGE

    Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults.

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 

    IMPORTANT SAFETY INFORMATION

    Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin.

    Talicia is contraindicated in patients receiving rilpivirine-containing products.

    Talicia is contraindicated in patients receiving delavirdine or voriconazole.

    Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin.

    Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy.

    Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia.

    Talicia should not be used in patients with hepatic impairment or severe renal impairment.

    Acute Interstitial Nephritis has been observed in patients taking PPIs and penicillins.

    Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease.

    The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

    To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Full prescribing information for Talicia is available at www.Talicia.com

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and commercial products; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and maintaining employment of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Chief Corporate & Business Development Officer

    RedHill Biopharma

    +972-54-6543-112

    Media contact (U.S.):

    Bryan Gibb

    Vice President

    Finn Partners

    +1 212 529 2236

     ____________________

    1 Omeprazole magnesium, amoxicillin and rifabutin delayed release capsules. Also referred to as RHB-105

    2 https://aspe.hhs.gov/pdf-report/carb-plan-2020-2025

    3 Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health

    Organization Regions. Alessia Savoldi et al. Gastroenterology 2018;155:1372–1382.

    4 Persistent H. pylori infection following participation in two randomized controlled trials: Outcomes of patients receiving physician-directed standard-of-care therapy. Colin W. Howden, Raymond M. Panas, June S. Almenoff, and Willian D. Chey.

    5 Efficacy of H. pylori eradication by low-dose rifabutin triple therapy (rhb-105) is unaffected by BMI: Post-hoc analysis from two Phase 3 trials. Kely L. Sheldon, Steven F. Moss, Mohd Amer Alsamman, Elliot Offman, Raymond M. Panas, and June S. Almenoff.

    6 Cerqueira, R. M., Correia, M. R., Fernandes, C. D., et al. (2013). Cumulative Helicobacter pylori eradication therapy in obese patients undergoing gastric bypass surgery. Obes Surg, 23(2), 145-149. doi:10.1007/s11695-012-0747-4.

    7 Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.

    8 The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001).

    9 Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429.

    10 IQVIA Custom Study for RedHill Biopharma, 2019

    11 Lamb A et al. Role of the Helicobacter pylori‐Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497.

    12 NIH – Helicobacter pylori and Cancer, September 2013.

    13 Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15.

    14 National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER).

    15 Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45.

    16 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    17 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    18 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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  27. RHB-204 Phase 3 study in pulmonary NTM infections is planned to be initiated in the coming weeks
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    Orphan Drug Designation, along with RHB-204's FDA QIDP priority designation, will extend U.S. potential market exclusivity to a total of 12 years

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 14, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to RHB-204 for the treatment of nontuberculous mycobacteria (NTM) disease.

    "NTM infections are resistant to most antibiotics and are extremely challenging to treat. With no FDA-approved first-line therapy available to patients…

    RHB-204 Phase 3 study in pulmonary NTM infections is planned to be initiated in the coming weeks

    --

    Orphan Drug Designation, along with RHB-204's FDA QIDP priority designation, will extend U.S. potential market exclusivity to a total of 12 years

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 14, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to RHB-204 for the treatment of nontuberculous mycobacteria (NTM) disease.

    "NTM infections are resistant to most antibiotics and are extremely challenging to treat. With no FDA-approved first-line therapy available to patients today, there is a tremendous urgent need for new treatments for this debilitating and potentially fatal infectious disease," said Patricia Anderson, RedHill's VP Regulatory Affairs. "Along with the QIDP designation already granted to RHB-204 by the FDA, the Orphan Drug Designation extends potential market exclusivity to a total of 12 years."

    A Phase 3 study to evaluate the safety and efficacy of RHB-204 in patients with pulmonary NTM infections caused by Mycobacterium avium Complex (MAC) is planned to be initiated in the coming weeks in the U.S.

    The multi-center, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study, under ongoing discussion with the FDA, is planned to be conducted at up to 40 sites across the U.S. and aims to enroll 125 patients, randomized at a 3:2 ratio to receive either RHB-204 or placebo. The study is planned to evaluate the safety and efficacy of RHB-204, evaluating patient-reported outcomes and sputum culture conversion (SCC) by Month 6 of treatment with RHB-204, compared to placebo, and patients will continue to receive treatment for 12 months from SCC.

    The FDA grants orphan status to drugs intended to treat rare disorders that affect fewer than 200,000 people in the U.S. The designation provides various development incentives to the drug developer, including extended market exclusivity upon FDA approval, prescription drug user fee (PDUFA) waivers and tax credits for qualified clinical testing.

    RHB-204 was previously granted a Qualified Infectious Disease Product (QIDP) designation by the FDA, providing for eligibility for Fast-Track development, NDA priority review and a five-year extension of U.S. market exclusivity, if approved. The Orphan Drug Designation extends U.S. market exclusivity for RHB-204 by an additional seven years, for a potential total of 12 years upon FDA approval.

    About Pulmonary Nontuberculous Mycobacteria (NTM) Infections

    Pulmonary nontuberculous mycobacteria (NTM) disease is a chronic and debilitating lung disease caused by ubiquitous environmental bacteria, found in soil as well as natural and engineered water systems. The most common NTM symptoms include fever, weight loss, chest pain, and blood in sputum1. NTM infections can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure2. Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world3. There were an estimated 110,000 pulmonary NTM disease patients in the U.S. in 20174. Pulmonary manifestations account for 80-90% of all NTM-associated diseases5, and approximately 80% of pulmonary NTM infections are caused by Mycobacterium avium Complex (MAC)6.

    Treatment of NTM infection can be difficult, with no FDA-approved first-line standard-of-care therapy. It requires multiple antibiotics and an extended treatment course due to the risk of development of resistance7. Many patients fail these types of therapies and more than half will have either recurring disease or a new infection after completing treatment8. Thus, new treatment options for NTM are urgently needed.

    About RHB-204

    RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM infections caused by Mycobacterium avium Complex (MAC). RHB-204 was granted both FDA Orphan Drug Designation for the treatment of NTM disease and QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. market exclusivity for RHB-204 to a potential total of 12 years to be granted at the time of FDA approval. RHB-204 is also covered by U.S. patents which extend patent protection until 2029 and a pending U.S. patent application which, if allowed, could extend RHB-204 patent protection until 2041.

           

    About RedHill Biopharma           

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults9, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults10, and Aemcolo® for the treatment of travelers' diarrhea in adults11. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company will not initiate the Phase 3 clinical study in all or part of the sites in the U.S. or will be delayed; the risk that the U.S. Phase 3 clinical study evaluating RHB-204 will not be successful or, if successful, will not suffice for regulatory marketing approval without the need for additional clinical and/or other studies; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Senior VP Business Development & Licensing

    RedHill Biopharma

    +972-54-6543-112

    IR contact (U.S.):

    Timothy McCarthy, CFA, MBA

    Managing Director, Relationship Manager

    LifeSci Advisors, LLC

    +1-212-915-2564

     

     

    1 Kim RD, et al. Pulmonary Nontuberculous Mycobacterial Disease. Prospective Study of a Distinct Preexisting Syndrome Am J Respir Crit Care Med. 2008; 178(10):1066–74.

    2 The American Lung Association, 2020.

    3 Henkle E, et al. Population-based Incidence of Pulmonary Nontuberculous Mycobacterial Disease in Oregon 2007 to 2012 Annals of the American Thoracic Society. 2015; 12(5):642-7.

    4 Foster|Rosenblatt, 2017

    5 Griffith DE, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases Am J Respir Crit Care Med. 2007;175(4):367-416.

    6 Prevots DR et al. Nontuberculous mycobacterial lung disease prevalence at four integrated health care delivery systems. Am J Respir Crit Care Med 2010; 182:970-76; Winthrop KL, et al. Pulmonary nontuberculous mycobacterial disease prevalence and clinical features: an emerging public health disease. Am J Respir Crit Care Med 2010; 182: 977-82

    7 Daley CL, et al. Treatment of Nontuberculous Mycobacterial Pulmonary Disease: An Official ATS/ERS/ESCMID/IDSA Clinical Practice Guideline: Executive Summary. Clinical Infectious Diseases. Ciaa241,  https://doi.org/10.1093/cid/ciaa241.

    8 Henkle E, et al. Patient-Centered Research Priorities for Pulmonary Nontuberculous Mycobacteria (NTM) Infection. An NTM Research Consortium Workshop Report Annals of the American Thoracic Society 2016; S379-84. 

    9 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com. 

    10 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.        

    11 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com. 

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  28.         Collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing further strengthens manufacturing capabilities and capacity, in preparation for potential emergency use applications 

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          Enrollment in the global Phase 2/3 COVID-19 study with opaganib is advancing rapidly following approvals in 6 countries
    --
    U.S. Phase 2 COVID-19 study with opaganib is approaching completion of enrollment and recently passed a second independent committee review

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 13, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced collaborations with two specialist pharmaceutical manufacturers…

            Collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing further strengthens manufacturing capabilities and capacity, in preparation for potential emergency use applications 

    --

          Enrollment in the global Phase 2/3 COVID-19 study with opaganib is advancing rapidly following approvals in 6 countries

    --

    U.S. Phase 2 COVID-19 study with opaganib is approaching completion of enrollment and recently passed a second independent committee review

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 13, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced collaborations with two specialist pharmaceutical manufacturers in Europe and Canada to ramp-up manufacturing of opaganib, currently in swiftly progressing global Phase 2/3 and U.S. Phase 2 studies for severe COVID-19 pneumonia, to support potential emergency use applications and subsequent demand.

    "In light of the rapid progress of our Phase 2/3 COVID-19 development program with opaganib, we are expanding manufacturing capabilities and capacity for opaganib with trusted and high-quality partners, to meet likely demand ahead of potential global emergency use applications," said Reza Fathi, PhD., RedHill's Senior VP, R&D.

    Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood of viral resistance.

    The late-stage development program for opaganib in patients with severe COVID-19 pneumonia includes: The U.S. Phase 2 study (NCT04414618), ongoing in eight clinical trial sites, is approaching completion of enrollment, and recently passed a second independent committee review, with data expected to follow before the end of this year; and the global Phase 2/3 study (NCT04467840), which is enrolling rapidly across 15 study sites and is on track to enroll up to 270 patients by the end of the year. Both studies are randomized, double-blind, parallel-arm, placebo-controlled trials with opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.

    Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue.

    The Company is in discussions with U.S. government agencies around potential funding to support the rapid advancement of opaganib toward potential emergency use applications and manufacturing scale-up.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of COVID-19.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies1 have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    Under a compassionate use program, COVID-19 patients (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published2. Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

    About RedHill Biopharma           

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults2, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults3, and Aemcolo® for the treatment of travelers' diarrhea in adults4. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be successful; the risk of a delay in receiving data to support emergency use applications or in making such emergency use applications, if at all; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that completion of enrollment for this clinical study and the data from this clinical study will be delayed if at all; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful and that enrollment will be delayed; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Senior VP Business Development & Licensing

    RedHill Biopharma

    +972-54-6543-112

    IR contact (U.S.):

    Timothy McCarthy, CFA, MBA

    Managing Director, Relationship Manager

    LifeSci Advisors, LLC

    +1-212-915-2564

     

    __________________________________

    1
    Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    2 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    3 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    4 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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  29. RedHill obtains Israel rights to Movantik® from AstraZeneca, giving RedHill global rights, excluding Europe and Canada
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    Movantik approved for opioid-induced constipation in Israel under the brand name Moventig®
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    RedHill to evaluate partnering opportunities for commercialization of Movantik in Israel
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    RedHill maintains sole and exclusive U.S. commercialization responsibility for Movantik, which generated approximately $20 million in net revenue in Q2/2020, the first quarter of sales as a RedHill product

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 08, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has gained the rights to Movantik (naloxegol…

    RedHill obtains Israel rights to Movantik® from AstraZeneca, giving RedHill global rights, excluding Europe and Canada

    --

    Movantik approved for opioid-induced constipation in Israel under the brand name Moventig®

    --

    RedHill to evaluate partnering opportunities for commercialization of Movantik in Israel

    --

    RedHill maintains sole and exclusive U.S. commercialization responsibility for Movantik, which generated approximately $20 million in net revenue in Q2/2020, the first quarter of sales as a RedHill product

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 08, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has gained the rights to Movantik (naloxegol)1 in Israel from AstraZeneca (NASDAQ:AZN). RedHill now holds the worldwide rights to Movantik, excluding Europe and Canada.

    Movantik is approved in Israel, under the brand name Moventig, for the treatment of opioid-induced constipation (OIC) but is not yet commercialized. RedHill is evaluating the potential for a local commercialization partnership for Movantik in order to bring this valuable OIC treatment to patients in Israel.

    "Our commercial focus for Movantik remains firmly fixed on the U.S., where we have sole and exclusive commercialization rights. We have built a strong and expanding commercial team to support Movantik, which despite the challenging COVID-19 pandemic environment generated approximately $20 million in net revenue in the second quarter of 2020 - its first quarter as a RedHill product." said Adi Frish, Senior Vice President Business Development and Licensing at RedHill. "We would like to thank AstraZeneca for expanding our Movantik partnership and Knight Therapeutics, which previously held the rights for Moventig in Israel, for enabling the smooth transfer of this asset."

    In August this year, the Company also announced an amendment to the agreement with Daiichi Sankyo which enabled RedHill to exercise full control over brand strategy and commercialization activities for Movantik in the U.S., while also increasing margins.

    About Movantik®

    Movantik is a proprietary once-daily oral PAMORA approved by the U.S. Food and Drug Administration for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dosage escalation. Movantik is the first oral PAMORA approved in the U.S. for the treatment of OIC and is recommended by the American Gastroenterological Association (AGA) guidelines2 and the National Comprehensive Cancer Network (NCCN) guidelines. Movantik is part of the exclusive worldwide license agreement announced in 2009 between AstraZeneca and Nektar Therapeutics. It was developed using Nektar's oral small-molecule polymer conjugate technology. Movantik® was first approved in 2014 and launched in the U.S. by AstraZeneca and Daiichi Sankyo in 2015. Further information about Movantik is available at: www.Movantik.com.

    About Opioid-Induced Constipation (OIC)

    OIC is a condition caused by prescription opioid pain medicines. Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they can also bind to mu-receptors in the bowel, which can result in patients suffering from OIC. OIC is the most prevalent and disabling adverse effect associated with opioid therapy, estimated to affect between 40-80% of the millions of patients taking chronic opioid therapy each year4.

    About RedHill Biopharma           

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults3, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults4 and Aemcolo® for the treatment of travelers' diarrhea in adults5. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and ongoing Phase 2 studies for prostate cancer and cholangiocarcinoma; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.           

    IMPORTANT SAFETY INFORMATION ABOUT MOVANTIK

    MOVANTIK may cause serious side effects, including:

    • Opioid withdrawal. You may have symptoms of opioid withdrawal during treatment with MOVANTIK, including sweating, chills, diarrhea, stomach pain, anxiety, irritability, and yawning. Patients taking methadone to treat their pain may be more likely to experience stomach pain and diarrhea. Tell your doctor if you have any of these symptoms
    • Severe Stomach Pain and/or Diarrhea. This can happen within a few days of starting MOVANTIK and can lead to hospitalization. If either of these side effects occurs, stop taking MOVANTIK and call your doctor immediately
    • Tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that gets worse or does not go away, stop taking MOVANTIK and get emergency medical help right away

    Do not take MOVANTIK if you:

    • Have a bowel blockage (intestinal obstruction) or have a history of bowel blockage
    • Are allergic to MOVANTIK or any of the ingredients in MOVANTIK

    MOVANTIK can interact with other medicines and cause side effects, including opioid withdrawal symptoms (see symptoms above). Tell your doctor or pharmacist before you start or stop any medicines during treatment with MOVANTIK

    Before you take MOVANTIK, tell your doctor about all of your medical conditions, including if you:

    • Have any stomach, bowel (intestines) problems, including inflammation in parts of the large intestine (diverticulitis), or inflammation and injury of the intestines caused by reduced blood flow (ischemic colitis)
    • Have had recent surgery on the stomach or intestines
    • Have any kidney, or liver problems
    • Are pregnant or plan to become pregnant. Taking MOVANTIK during pregnancy may cause opioid withdrawal symptoms in you or your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with MOVANTIK
    • Are breastfeeding or plan to breastfeed. It is not known if MOVANTIK passes into your breast milk. Taking MOVANTIK while you are breastfeeding may cause opioid withdrawal in your baby. You and your healthcare provider should decide if you will take MOVANTIK or breastfeed. You should not breastfeed if you take MOVANTIK

    Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect the way MOVANTIK works

    If you stop taking your opioid pain medicine, stop taking MOVANTIK and tell your doctor

    Avoid eating grapefruit or drinking grapefruit juice during treatment with MOVANTIK

    The most common side effects of MOVANTIK include: Stomach (abdomen) pain, diarrhea, nausea, gas, vomiting, headache, and excessive sweating

    APPROVED USE FOR MOVANTIK

    MOVANTIK is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids, in adults with long-lasting (chronic) pain that is not caused by active cancer.

    You are encouraged to report Adverse Reactions to RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that the Company will be unable to enter into a local commercialization partnership for Movantik® in Israel and risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and commercial products; (v) the Company's ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and maintaining employment of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Senior VP Business Development & Licensing

    RedHill Biopharma

    +972-54-6543-112

    IR contact (U.S.):

    Timothy McCarthy, CFA, MBA

    Managing Director, Relationship Manager

    LifeSci Advisors, LLC

    +1-212-915-2564

    _______________

    i Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com; Approved in Israel under brand name Moventig®.

    ii Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.

    iii Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    iv Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    v Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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  30. Second pre-scheduled independent Safety Monitoring Committee (SMC) review unanimously recommends continuation without change of the U.S. Phase 2 study with opaganib in COVID-19 
    --
    The U.S. Phase 2 study is 75% enrolled with data expected later this quarter
    --
    In parallel, enrollment advancing rapidly in the global COVID-19 Phase 2/3 study with opaganib 
    --
    Global emergency use authorization applications are planned, subject to positive clinical results

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 07, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Phase 2 study with opaganib (Yeliva®, ABC294640)1 in patients hospitalized with severe…

    Second pre-scheduled independent Safety Monitoring Committee (SMC) review unanimously recommends continuation without change of the U.S. Phase 2 study with opaganib in COVID-19 

    --

    The U.S. Phase 2 study is 75% enrolled with data expected later this quarter

    --

    In parallel, enrollment advancing rapidly in the global COVID-19 Phase 2/3 study with opaganib 

    --

    Global emergency use authorization applications are planned, subject to positive clinical results

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 07, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Phase 2 study with opaganib (Yeliva®, ABC294640)1 in patients hospitalized with severe COVID-19 pneumonia has passed its second pre-scheduled safety review by the independent Safety Monitoring Committee (SMC) with a unanimous recommendation to continue the study without change. The SMC's recommendation is based on an unblinded analysis of safety data from the first 24 patients treated in the study for at least seven days. The study is 75% enrolled.

    The U.S. Phase 2 study with opaganib (NCT04414618), ongoing in eight clinical trial sites, is planned to complete enrollment this month, with data expected to follow before the end of this year. The Phase 2 study is not powered for efficacy and is focused on safety evaluation and identifying a signal of efficacy.

    In parallel, the global Phase 2/3 study with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) is rapidly enrolling across 15 study sites and is on track to enroll up to 270 patients. This study is focused on, and powered for, efficacy evaluation. The study has been approved in the UK, Italy, Russia, Mexico, Brazil and Israel, with further expansion ongoing.

    "Passing this second pre-scheduled independent safety review, involving data from 60% of the patients in the study, is an important milestone in the ongoing development of opaganib as a potential therapy for patients with severe COVID-19," said Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill. "We are rapidly building more data and experience with opaganib, with the safety database from opaganib studies now numbering close to 200 patients. This further supports the ongoing global Phase 2/3 study which is focused on delivering efficacy and is on track to enroll up to 270 patients by the end of the year."

    RedHill is in discussions with U.S. government agencies around potential funding to support the rapid advancement of opaganib toward potential emergency use approval and manufacturing scale-up.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood of viral resistance. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of severe COVID-19.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies2 have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    Under a compassionate use program, patients with COVID-19 (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published2. Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

           

    About RedHill Biopharma           

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults3, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults4, and Aemcolo® for the treatment of travelers' diarrhea in adults5. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be successful; the risk that the antiviral activity of opaganib shown in the preclinical human lung cell model will not be demonstrated in clinical trials; the risk of a delay in receiving data to support emergency use applications; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the risk that clinical trials with opaganib in Brazil, Israel, the U.S., Italy, Russia, the UK, Mexico or elsewhere for the treatment of COVID-19, if conducted at all, will not show any improvement in patients; the risk of a delay in applying for emergency use authorizations, if at all; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Senior VP Business Development & Licensing

    RedHill Biopharma

    +972-54-6543-112

    IR contact (U.S.):

    Timothy McCarthy, CFA, MBA

    Managing Director, Relationship Manager

    LifeSci Advisors, LLC

    +1-212-915-2564

     

    1 Opaganib is an investigational new drug, not available for commercial distribution.

    2 Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    3 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com. 

    4 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.    

    5 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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  31. TEL AVIV, Israel and RALEIGH, N.C., Oct. 06, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in October:

    BIO Investor Forum Digital (Oct. 13-15)
    Speaker: Guy Goldberg, Chief Business Officer

    BIO-Europe 2020 Digital (Oct. 26-29)
    Speaker: Adi Frish, Senior VP Business Development and Licensing

    The presentations will be available on the Company's website http://ir.redhillbio.com/events from the start of each conference for 30 days.

    About RedHill Biopharma           
    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases…

    TEL AVIV, Israel and RALEIGH, N.C., Oct. 06, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will present at the following virtual conferences in October:

    BIO Investor Forum Digital (Oct. 13-15)

    Speaker: Guy Goldberg, Chief Business Officer

    BIO-Europe 2020 Digital (Oct. 26-29)

    Speaker: Adi Frish, Senior VP Business Development and Licensing

    The presentations will be available on the Company's website http://ir.redhillbio.com/events from the start of each conference for 30 days.

    About RedHill Biopharma           

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults1, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults2, and Aemcolo® for the treatment of travelers' diarrhea in adults3. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

    Company contact:

    Adi Frish

    Senior VP Business Development & Licensing

    RedHill Biopharma

    +972-54-6543-112

    IR contact (U.S.):

    Timothy McCarthy, CFA, MBA

    Managing Director, Relationship Manager

    LifeSci Advisors, LLC

    +1-212-915-2564

     

    ____________________________

    1 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    2 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

    3 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com

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  32. Veeva Vault CDMS and Bioforum selected to optimize clinical data management for RedHill's global Phase 2/3 clinical trial evaluating opaganib in patients with severe COVID-19

    Veeva Systems (NYSE:VEEV) ("Veeva") and Bioforum today announced their collaboration with RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill") on a global Phase 2/3 clinical study evaluating opaganib (Yeliva®, ABC294640),1 a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, in patients hospitalized with severe COVID-19 pneumonia requiring treatment with supplemental oxygen.

    The opaganib Phase 2/3 study is set to enroll up to 270 patients in up to 40 clinical sites around the world and collect broad and rigorous data in a short amount of…

    Veeva Vault CDMS and Bioforum selected to optimize clinical data management for RedHill's global Phase 2/3 clinical trial evaluating opaganib in patients with severe COVID-19

    Veeva Systems (NYSE:VEEV) ("Veeva") and Bioforum today announced their collaboration with RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill") on a global Phase 2/3 clinical study evaluating opaganib (Yeliva®, ABC294640),1 a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, in patients hospitalized with severe COVID-19 pneumonia requiring treatment with supplemental oxygen.

    The opaganib Phase 2/3 study is set to enroll up to 270 patients in up to 40 clinical sites around the world and collect broad and rigorous data in a short amount of time. To support the study, RedHill has adopted Veeva Vault CDMS, a modern cloud platform for electronic data capture (EDC), coding, data cleaning, and reporting. Vault CDMS provides RedHill with a flexible EDC that simplifies and streamlines processes for building and deploying clinical studies. Bioforum, a global data-focused contract research organization (CRO) and a certified Veeva partner, has been selected by RedHill, a long-time client, to implement and configure Vault CDMS for this COVID-19 study.

    "With its unique dual anti-inflammatory and anti-viral mechanisms, opaganib has the potential to inhibit the key drivers of disease progression and address the serious unmet medical need for safe, effective, and life-saving treatments for patients with severe COVID-19," said Aida Bibliowicz, vice president of clinical affairs at RedHill. "Our immediate goal is to compile clinical data as early as the fourth quarter of 2020 to support potential applications for emergency use authorizations of opaganib. As such, efficiency in our studies and the quality and integrity of our trial data is absolutely critical, and we are pleased to partner with Bioforum and Veeva to help ensure this."

    Vault CDMS enables trial sponsors and their CRO partners to manage studies collaboratively from build through execution. Veeva Vault EDC, part of Vault CDMS, provides an intuitive interface for capturing trial data and is designed for flexibility, enabling teams to create study builds faster and make mid-study changes with no downtime.

    "RedHill's opaganib is an exciting, needed drug candidate to overcome the pandemic," said Henry Levy, general manager, Vault CDMS, sites and patients at Veeva Systems. "We're thrilled that our technology and partnership with Bioforum are helping to drive innovation and look forward to working alongside RedHill in advancing this important treatment with the potential to save lives and improve the health of COVID-19 patients."

    Bioforum's co-founder and president Amir Malka added: "We're proud to be contributing to this important COVID-19 study. This continues our long-term partnership with RedHill, supporting their efforts to rapidly advance global clinical development programs and deliver therapies that make a meaningful difference in patients' lives. We're confident that together with Veeva, we can help clients like RedHill improve efficiencies in all stages of clinical development — from study design and start-up through execution and submission."

    To learn more about opaganib (Yeliva®, ABC294640) clinical trials, please visit www.redhillbio.com.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-inflammatory, and anti-viral activities, targeting multiple oncology, viral, inflammatory, and gastrointestinal indications. By inhibiting SK2, opaganib impacts multiple cellular pathways which are associated with cancer growth, viral replication, and pathological inflammation.

    Opaganib received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of coronavirus (COVID-19).

    Pre-clinical data have demonstrated both anti-inflammatory and anti-viral activities of opaganib, with the potential to reduce lung inflammatory disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent anti-viral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, pre-clinical in vivo studies2 have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors.

    Under a compassionate use program, COVID-19 patients (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have recently been published.3 Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital without requiring mechanical ventilation, whereas 33% of the matched case-control group required mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group. The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense, and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.clinicaltrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

    About RedHill Biopharma

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults,i Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults,ii and Aemcolo® for the treatment of travelers' diarrhea in adults.iii RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis, and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    About Bioforum the Data Masters

    Bioforum is a data-focused contract research organization (CRO), serving clients worldwide in optimizing the collection, standardization, and reporting of clinical research data. We strive to consistently improve and innovate data processes, enabling the most efficient data submissions for our clients across the life sciences industry worldwide. From our offices in Israel, the U.S., Australia, and South Africa, our multidisciplinary team provides in-depth expertise and delivers high-quality solutions, including medical writing, data management, clinical programming, biostatistics, and pharmacovigilance. To learn more about us and our services, visit bioforumgroup.com or find us on LinkedIn at linkedin.com/company/bioforum-ltd.

    Additional Information

    For more on Veeva Vault CDMS, visit: veeva.com/cdms

    Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems

    Follow @veevasystems on Twitter: twitter.com/veevasystems

    Like Veeva on Facebook: facebook.com/veevasystems

    About Veeva Systems

    Veeva Systems Inc. is a leader in cloud solutions—including data, software, and services—for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 900 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. The company is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.

    Forward-looking Statements Regarding Veeva and its Products

    This release contains forward-looking statements, including the market demand for and acceptance of Veeva's products and services, the results from use of Veeva's products and services, and general business conditions (including the on-going impact of COVID-19), particularly within the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva's historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva's expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva's financial results are included under the captions, "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations," in the company's filing on Form 10-Q for the period ended July 31, 2020. This is available on the company's website at veeva.com under the Investors section and on the SEC's website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.

    Forward-looking Statements Regarding RedHill and Opaganib

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk of a delay in compiling clinical data to support potential applications for emergency use authorizations of opaganib; the risk that the antiviral activity in the in vitro study will not be demonstrated in clinical trials; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that completion of enrollment for this clinical study will be delayed; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study in additional countries and that it will not be successful; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the risk of a delay in applying for emergency use authorizations; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals, and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements, and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.


    1 Opaganib is an investigational new drug, not available for commercial distribution.

    2 Antiviral Res., Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice, 2018

    3 MedRxRiv, Compassionate Use of Opaganib For Patients with Severe COVID-19, 2020


    i Full prescribing information for Movantik (naloxegol) is available at: www.Movantik.com.

    ii Full prescribing information for Talicia (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.

    iii Full prescribing information for Aemcolo (rifamycin) is available at: www.Aemcolo.com.

    ® 2020 Veeva Systems Inc. All rights reserved. Veeva and the Veeva logo are trademarks of Veeva Systems Inc.

    Veeva Systems Inc. owns other registered and unregistered trademarks.

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  33. The ongoing global Phase 2/3 study with orally-administered opaganib in patients with severe COVID-19 is approved in Italy, the UK, Russia, Israel, Mexico and Brazil; 16 clinical sites initiated globally to date
    --
    In parallel, the opaganib U.S. Phase 2 study, with 8 active clinical sites, is approximately 75% enrolled and expected to be completed in the coming weeks
    --
    Opaganib completely inhibited SARS-CoV-2 viral replication in an in vitro human lung cell model, comparing favorably with remdesivir, the positive control in the study
    --
    Opaganib demonstrated dual anti-inflammatory and antiviral activity and targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance
    --
    Global emergency use authorization

    The ongoing global Phase 2/3 study with orally-administered opaganib in patients with severe COVID-19 is approved in Italy, the UK, Russia, Israel, Mexico and Brazil; 16 clinical sites initiated globally to date

    --

    In parallel, the opaganib U.S. Phase 2 study, with 8 active clinical sites, is approximately 75% enrolled and expected to be completed in the coming weeks

    --

    Opaganib completely inhibited SARS-CoV-2 viral replication in an in vitro human lung cell model, comparing favorably with remdesivir, the positive control in the study

    --

    Opaganib demonstrated dual anti-inflammatory and antiviral activity and targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance

    --

    Global emergency use authorization applications planned, subject to positive clinical results

    TEL AVIV, Israel and RALEIGH, N.C., Sept. 22, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced approval from the Brazilian Health Regulatory Agency (ANVISA) for its ongoing global Phase 2/3 study evaluating opaganib1 in patients hospitalized with severe COVID-19 pneumonia. Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance.

    Gilead Raday, RedHill's Chief Operating Officer, said: "In recently announced preclinical results, opaganib demonstrated its ability to stop SARS-CoV-2 viral replication in its tracks - preventing its ability to spread and cause damage to other cells which, together with its potent anti-inflammatory mechanism, supports the rapid progress of our global Phase 2/3 and U.S. Phase 2 studies. Brazil continues to experience a significant number of COVID-19 cases and its addition is expected to further accelerate the global Phase 2/3 study with opaganib."

    The ongoing global multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study (NCT04467840) evaluating opaganib for the treatment of patients with severe COVID-19 pneumonia continues to enroll with a target of up to 270 patients requiring hospitalization and treatment with supplemental oxygen. The study has been approved in Brazil, Israel, United Kingdom, Italy, Russia and Mexico, with further expansion ongoing and progressing rapidly.

    In parallel, the randomized, double-blind, placebo-controlled U.S. Phase 2 study (NCT04414618) with opaganib in patients with severe COVID-19 pneumonia is approximately 75% enrolled, with enrollment set to be completed in the coming weeks. Recently, a pre-scheduled independent Safety Monitoring Committee recommended that the study continue without change. The study, which is not powered for statistical significance, is set to enroll up to 40 patients requiring hospitalization and supplemental oxygen.

    The Company is in discussions with U.S. government agencies around potential funding to support the rapid advancement of opaganib toward potential emergency use approval.

    About Opaganib (ABC294640, Yeliva®)

    Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-inflammatory, and antiviral activities, targeting multiple oncology, viral, inflammatory, and gastrointestinal indications.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated in a global Phase 2/3 study and a U.S. Phase 2 study for the treatment of COVID-19.

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce inflammatory lung disorders, such as pneumonia, and mitigate pulmonary fibrotic damage. Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies2 have demonstrated that opaganib decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids.

    Opaganib was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful preclinical studies in oncology, inflammation, GI, and radioprotection models, as well as a Phase 1 clinical study in cancer patients with advanced solid tumors and an additional Phase 1 study in multiple myeloma.

    Under a compassionate use program, COVID-19 patients (as classified by the WHO ordinal scale) were treated with opaganib in a leading hospital in Israel. Data from the treatment of these first patients with severe COVID-19 with opaganib have been published2. Analysis of treatment outcomes suggested substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital on room air without requiring intubation and mechanical ventilation, whereas 33% of the matched case-control group required intubation and mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.

    The development of opaganib has been supported by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including from the NCI, BARDA, the U.S. Department of Defense and the FDA Office of Orphan Products Development.

    The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.

    About RedHill Biopharma           

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults3, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults4, and Aemcolo® for the treatment of travelers' diarrhea in adults5. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that the Company's Phase 2/3 study evaluating opaganib will not be successful; the risk that the antiviral activity of opaganib shown in the preclinical human lung cell model will not be demonstrated in clinical trials; the risk of a delay in receiving data to support emergency use applications; the risk that the U.S. Phase 2 clinical study evaluating opaganib will not be successful and the risk that completion of enrollment for this clinical study will be delayed; the risk that the Company will not initiate the Phase 2/3 study for opaganib in certain geographies, will not expand this study to additional countries and that it will not be successful; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the risk that clinical trials with opaganib in Brazil, Israel, the U.S., Italy, Russia, the UK, Mexico or elsewhere for the treatment of COVID-19, if conducted at all, will not show any improvement in patients; the risk of a delay in applying for emergency use authorizations, if at all; the development risks of early-stage discovery efforts for a disease that is still little understood, including difficulty in assessing the efficacy of opaganib for the treatment of COVID-19, if at all; intense competition from other companies developing potential treatments and vaccines for COVID-19; the effect of a potential occurrence of patients suffering serious adverse events using opaganib under compassionate use programs, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company's industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

      
    Company contact:

    Adi Frish

    Senior VP Business Development & Licensing

    RedHill Biopharma

    +972-54-6543-112

    IR contact (U.S.):

    Timothy McCarthy, CFA, MBA

    Managing Director, Relationship Manager

    LifeSci Advisors, LLC

    +1-212-915-2564

    _____________________________

    1 Opaganib is an investigational new drug, not available for commercial distribution.

    2 Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

    3 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.

    4 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.        

    5 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

    Primary Logo

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  34. TEL AVIV, Israel and RALEIGH, N.C., Sept. 09, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill's Chief Executive Officer, Dror Ben-Asher, will present at the Morgan Stanley Annual Global Healthcare Conference, on Thursday, September 17, 2020.

    Morgan Stanley Virtual 18th Annual Global Healthcare Conference (Sept. 14-18)
    Fireside chat and Q&A: Thursday, September 17, 2020
    Time: 8:45 a.m. EDT
    Speaker: Dror Ben-Asher, Chief Executive Officer

    The Company will also present and hold one-on-one meetings at several additional events in September:

    The Sixth Annual PharmaVOICE 100 Celebration
    Bioforum Panel Presentation: Thursday…

    TEL AVIV, Israel and RALEIGH, N.C., Sept. 09, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that RedHill's Chief Executive Officer, Dror Ben-Asher, will present at the Morgan Stanley Annual Global Healthcare Conference, on Thursday, September 17, 2020.

    Morgan Stanley Virtual 18th Annual Global Healthcare Conference (Sept. 14-18)

    Fireside chat and Q&A: Thursday, September 17, 2020

    Time: 8:45 a.m. EDT

    Speaker: Dror Ben-Asher, Chief Executive Officer

    The Company will also present and hold one-on-one meetings at several additional events in September:

    The Sixth Annual PharmaVOICE 100 Celebration

    Bioforum Panel Presentation: Thursday, September 10, 2020

    Topic: Developing Clinical Trial Outsourcing Strategies that Scale as Biotechs Do

    Time: 12:10 a.m. EDT

    Speaker: Guy Goldberg, Chief Business Officer

    The Wall Street Investor Forum

    Presentation: Thursday, September 10, 2020

    Time: 11:40 a.m. EDT

    Speaker: Dror Ben-Asher, Chief Executive Officer

    H.C. Wainwright 22nd Annual Healthcare Conference (Sept. 14-16)

    Presentation and Q&A: Wednesday, September 16, 2020

    Time: 10:00 a.m. EDT

    Speaker: Guy Goldberg, Chief Business Officer

    Healthtech Leaders Virtual Partnering & Investment Conference (Sept. 15-18)

    Presentation: On-demand

    Speaker: Guy Goldberg, Chief Business Officer

    Sachs 20th Annual Biotech in Europe Forum (Sept. 21-24)

    Presentation: On-demand

    Speaker: Guy Goldberg, Chief Business Officer

    Panel: Virtual Therapeutic Strategies to Prevent & Treat COVID-19

    Date: Monday, September 21, 2020

    Time: 10:00 a.m. EDT/4:00 p.m. CET

    Speaker: Gilead Raday, Chief Operating Officer 

    All presentations will be broadcasted live and available via replay for 30 days on the Company's website: https://ir.redhillbio.com.

    About RedHill Biopharma      

    RedHill Biopharma Ltd. (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults1, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults2, and Aemcolo® for the treatment of travelers' diarrhea in adults3. RedHill's key clinical late-stage development programs include: (i) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva®), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB-106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties as well associated