RDHL Redhill Biopharma Ltd.

6.94
+0.15  (+2%)
Previous Close 6.79
Open 6.89
52 Week Low 3.2621
52 Week High 9.12
Market Cap $244,770,788
Shares 35,269,566
Float 35,269,566
Enterprise Value $227,778,353
Volume 111,867
Av. Daily Volume 425,143
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Drug Pipeline

Drug Stage Notes
Opaganib
COVID-19
Phase 2a
Phase 2a
Phase 2a U.S. trial is initiating enrolment - noted June 10, 2020.
RHB-204
Nontuberculous mycobacteria (NTM) infections
Phase 3
Phase 3
Phase 3 trial to be initiated 3Q 2020.
RHB-104 MAP
Crohn’s disease
Phase 3
Phase 3
Phase 3 data released July 30, 2018. Primary endpoint met but further trial required.
YELIVA
Cholangiocarcinoma
Phase 2a
Phase 2a
Phase 2a enrolment of second arm has been initiated - March 11, 2020.
BEKINDA
Gastroenteritis
Phase 3
Phase 3
Phase 3 additional trial planned.
Talicia RHB-105
H. pylori
Approved
Approved
FDA Approval announced November 4, 2019.
BEKINDA
IBS-D
Phase 2
Phase 2
Phase 2 top-line data released October 3, 2017 - primary endpoint met (borderline) - p=0.05. Follow up analysis identfied p value = 0.036. Phase 3 trial planned.

Latest News

  1. TEL-AVIV, Israel and RALEIGH, N.C., July 01, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Gilead Raday, RedHill's Chief Operating Officer, will present the Company's ongoing Phase 2/3 development programs with opaganib (Yeliva®, ABC294640)1 and RHB-107 (upamostat, WX-671)2 for COVID-19 at the Sachs Digital Novel Coronavirus Investment Forum, taking place July 7-9, 2020.

    The presentation will be available on the Company's website, http://ir.redhillbio.com/events on July 7, 2020 for a period of 30 days.

    In addition, Mr. Raday will participate in a panel discussion on the topic of ‘Potential Therapeutic Strategies to Prevent and…

    TEL-AVIV, Israel and RALEIGH, N.C., July 01, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Gilead Raday, RedHill's Chief Operating Officer, will present the Company's ongoing Phase 2/3 development programs with opaganib (Yeliva®, ABC294640)1 and RHB-107 (upamostat, WX-671)2 for COVID-19 at the Sachs Digital Novel Coronavirus Investment Forum, taking place July 7-9, 2020.

    The presentation will be available on the Company's website, http://ir.redhillbio.com/events on July 7, 2020 for a period of 30 days.

    In addition, Mr. Raday will participate in a panel discussion on the topic of ‘Potential Therapeutic Strategies to Prevent and Conquer Covid-19' on Wednesday, July 8, 2020, at 10:15 a.m. EDT/4:15 p.m. CET. The live panel can be accessed by conference attendees or by registering via https://www.sachsforum.com/ncif-registration.html.

    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.

    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. Several prior pre-clinical studies support the potential role of SK2 in the replication-transcription complex of positive-sense single-stranded RNA viruses, similar to coronavirus, and its inhibition may potentially inhibit viral replication. Pre-clinical 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 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.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 1/2a in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated for the treatment of coronavirus (COVID-19). 

    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.

    About RHB-107 (upamostat)

    RHB-107 is a proprietary, first-in-class, orally administered potent inhibitor of several serine proteases targeting cancer, inflammatory lung diseases, and gastrointestinal diseases. RedHill is currently pursuing a Phase 2/3 clinical development program with RHB-107 for COVID-19. RHB-107 has undergone several Phase 1 studies and two Phase 2 proof-of-concept studies demonstrating its clinical safety profile in over 300 patients across 10 clinical studies, including two completed Phase 2 studies in oncology patients and several Phase 1 studies in healthy volunteers and oncology patients. These studies helped establish the safety and tolerability of RHB-107 in humans. 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 diseases. RedHill promotes the gastrointestinal drugs: Movantik® for opioid-induced constipation in adults4, 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 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-106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. 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.

    __________________________________

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

    2 RHB-107 is an investigational new drug, not available for commercial distribution.

    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.

    Company contact:
    Adi Frish
    Senior VP Business Development & Licensing
    RedHill Biopharma
    +972-54-6543-112
    hillbio.com
    
    IR contact (U.S.):
    Timothy McCarthy, CFA, MBA
    Managing Director, Relationship Manager
    LifeSci Advisors, LLC
    +1-212-915-2564
    

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  2. The Phase 2/3 multi-center, randomized, double-blind, parallel-arm, placebo-controlled study with opaganib aims to enroll 270 severe COVID-19 patients in up to 40 clinical sites across the UK, Italy, Russia and additional countries 

    --

    In parallel, a U.S. study with opaganib in up to 40 severe COVID-19 patients has been initiated at leading medical centers

    TEL-AVIV, Israel and RALEIGH, N.C., June 29, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Company's Clinical Trial Authorization (CTA) application to commence a Phase 2/3 study evaluating opaganib (Yeliva…

    The Phase 2/3 multi-center, randomized, double-blind, parallel-arm, placebo-controlled study with opaganib aims to enroll 270 severe COVID-19 patients in up to 40 clinical sites across the UK, Italy, Russia and additional countries 

    --

    In parallel, a U.S. study with opaganib in up to 40 severe COVID-19 patients has been initiated at leading medical centers

    TEL-AVIV, Israel and RALEIGH, N.C., June 29, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Company's Clinical Trial Authorization (CTA) application to commence a Phase 2/3 study evaluating opaganib (Yeliva®, ABC294640)1 in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia. RedHill has also submitted CTA applications for this study in Russia and Italy and plans to expand the study to additional countries.

    Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, stated: "This timely approval from the UK regulatory authority for the Phase 2/3 study with opaganib comes as the global infection rates continue to grow and there remains a serious unmet medical need for a safe and effective treatment for COVID-19. We are rapidly advancing our COVID-19 program with opaganib, including the recently initiated Phase 2a study in leading U.S. centers."

    The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study is set to enroll up to 270 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy. The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14. An unblinded futility only interim analysis will be conducted by an independent data safety monitoring board (DSMB) when approximately 100 subjects have been evaluated for the primary endpoint. The study is planned to be conducted in clinical sites across Italy, the UK, Russia and additional countries.

    In parallel, RedHill has initiated enrollment for a randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S. (NCT04414618). This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. This clinical trial is not powered for statistical significance. 

    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.

    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. Several prior pre-clinical studies support the potential role of SK2 in the replication-transcription complex of positive-sense single-stranded RNA viruses, similar to coronavirus, and its inhibition may potentially inhibit viral replication. 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.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 1/2a in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated for the treatment of coronavirus (COVID-19). 

    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.

    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-106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. 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 clinical condition of the patients treated with opaganib will not continue to improve and may worsen, the risk that the U.S. Phase 2a clinical study evaluating opaganib will not be successful; the risk that the Company will not initiate the Phase 2/3 study in Russian, Italy or the UK and will not expand this study to a multinational study with sites in additional countries; the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the risk that clinical trials of opaganib in Israel, the U.S., Italy, Russia, the UK or elsewhere for the treatment of COVID-19, if conducted at all, will not show any improvement in patients; 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 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 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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  3. Analysis of treatment outcomes in five severe COVID-19 patients showed substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a 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
    --
    Phase 2/3 Clinical Trial Applications submitted for a multi-center, randomized, double-blind, parallel-arm, placebo-controlled

    Analysis of treatment outcomes in five severe COVID-19 patients showed substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a 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

    --

    Phase 2/3 Clinical Trial Applications submitted for a multi-center, randomized, double-blind, parallel-arm, placebo-controlled study with opaganib in 270 patients with severe COVID-19 to be conducted in up to 40 clinical sites across Russia, Italy, the UK and additional countries

    --

    A randomized, double-blind, placebo-controlled study with opaganib in up to 40 patients with  severe COVID-19 initiated at leading medical centers across the U.S.

    TEL-AVIV, Israel and RALEIGH, N.C., June 24, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that results from the treatment of the first severe COVID-19 patients with its investigational drug, opaganib (Yeliva®, ABC294640)1, have been published in medRxiv.

    The article2, entitled ‘Compassionate Use of Opaganib For Patients with Severe COVID-19' was published under an expedited process and is available publicly.

    Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, stated: "We are very encouraged by the analysis from severe COVID-19 patients treated with opaganib to date, demonstrating substantial benefit to patients in both clinical outcomes and inflammatory markers as compared to a matched case-control group. This data further supports our intensive efforts to rapidly advance the development of opaganib via the recently initiated Phase 2a clinical study under IND with the FDA and the Phase 2/3 study in European and other countries which we expect to initiate shortly, as well as through ongoing and planned compassionate use programs."

    Seven patients with severe3 COVID-19 were treated with opaganib under compassionate use in a leading hospital in Israel. Prior to treatment initiation, these patients were hospitalized and required treatment with supplemental oxygen via high-flow nasal cannula while being treated with standard-of-care. Opaganib was given on top of standard-of-care therapy. Five patients were included in the final published analysis4 of the active arm. An investigator-selected matched case-control group of patients with similar baseline characteristics at the same hospital was identified for comparison (n=18).

    A comparison of outcomes between patients treated with opaganib and the matched case-controls treated with standard-of-care alone for both clinical and inflammatory measures revealed:

    • All patients in the opaganib-treated group were discharged from hospital on room air, without having required mechanical ventilation, whereas 33% of patients in the 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 control group.

       
    • Improvement in lymphocyte counts was faster in opaganib-treated patients as compared to patients in the control group.

       
    • C-reactive protein (an inflammatory marker) showed faster improvement in the opaganib treated group as compared to the control group.

       
    • In this cohort of severe COVID-19 patients, opaganib was found safe and well tolerated and improvement in clinical and laboratory parameters was demonstrated for opaganib-treated patients compared to matched case-controls.  

    To find out more about RedHill Biopharma's Expanded Access policy, please visit: www.redhillbio.com/expandedaccess.

    A randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S. is open for recruitment (NCT04414618). This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. This clinical trial is not powered for statistical significance. 

    In parallel, the Company has submitted Clinical Trial Applications (CTA) in Russia, Italy and the UK for a multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study with opaganib in patients hospitalized with severe COVID-19. This study is planned to commence shortly and enroll up to 270 subjects across up to 40 clinical sites in these European and other countries.

    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, inflammatory and gastrointestinal indications. By inhibiting SK2, opaganib blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation.

    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. Several prior pre-clinical studies support the potential role of SK2 in the replication-transcription complex of positive-strand single-stranded RNA viruses, similar to coronavirus, and its inhibition may potentially inhibit viral replication. Pre-clinical in vivo studies5 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.

    Opaganib received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 1/2a in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Opaganib is also being evaluated for the treatment of coronavirus (COVID-19). 

    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.

    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 adults6, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults7 and Aemcolo® for the treatment of travelers' diarrhea in adults8. 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-106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. 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, including forward-looking statements regarding the preliminary findings from the treatment of COVID-19 patients with opaganib and the Company's discussions to increase the accessibility of opaganib under compassionate use program authorizations programs. The treatment with opaganib in Israel is administered under a compassionate use program in accordance with the Israeli Ministry of Health guidelines. The findings to date are only preliminary, are based on clinical results of a very limited number of patients and are not part of a clinical study. There is no guarantee that these patients will continue to show clinical improvement or that other patients will show similar clinical improvement. 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 clinical condition of the patients treated with opaganib will not continue to improve and may worsen, the risk that the Company will not expand access to opaganib under compassionate use and clinical development programs in other territories, the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement, the risk that clinical trials of opaganib in Israel, the U.S., Italy or elsewhere for the treatment of COV-19, if conducted at all, will not show any improvement in patients, 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 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 Opaganib is an investigational new drug, not available for commercial distribution.

    2 The 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.

    3 Definition based on U.S. Food and Drug Administration (FDA) guidance published on May 12, 2020.

    4 Of the six patients who received more than one day of opaganib, one patient improved rapidly and was discharged from the hospital after only two doses. Hence, five patients who were administered more than one day of opaganib were included in the active group. A seventh patient was started on hydroxychloroquine, azithromycin and opaganib within 24 hours, and had all 3 drugs stopped due to diarrhea after only one day of treatment with opaganib. Eighteen matched case-controls (same sex, same severity and similar background medication) from the treating hospital were retrospectively identified.

    5 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.

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

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

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

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  4. TEL-AVIV, Israel and RALEIGH, N.C., June 22, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Guy Goldberg, RedHill's Chief Business Officer, will present a corporate overview at the Virtual Life Sciences Investor Forum on Thursday, June 25, 2020, at 10 a.m. EDT.

    This will be a live, online presentation where the audience is invited to ask the Company questions in real-time. The live broadcast and Q&A session can be accessed via the Company's website: http://ir.redhillbio.com/events. Please access the website at least 15 minutes ahead of the presentation to register.

    A replay of the presentation will be available for 30 days via the Company's…

    TEL-AVIV, Israel and RALEIGH, N.C., June 22, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Guy Goldberg, RedHill's Chief Business Officer, will present a corporate overview at the Virtual Life Sciences Investor Forum on Thursday, June 25, 2020, at 10 a.m. EDT.

    This will be a live, online presentation where the audience is invited to ask the Company questions in real-time. The live broadcast and Q&A session can be accessed via the Company's website: http://ir.redhillbio.com/events. Please access the website at least 15 minutes ahead of the presentation to register.

    A replay of the presentation will be available for 30 days via the Company's website: http://ir.redhillbio.com/events.           

    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 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-106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at www.redhillbio.com.

    About Life Sciences Investor Forum

    Life Sciences Investor Forum is the leading proprietary investor conference series that provides an interactive forum for Life Sciences companies to meet with and present directly to investors.

    A real-time solution for investor engagement, Life Sciences Investor Forum is powered by Intrado Digital Media and specifically designed for more efficient investor access. Replicating the look and feel of on-site investor conferences, Life Sciences Investor Forum combines leading-edge conferencing and investor communications capabilities with a comprehensive global investor audience network.

    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.

    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.

    Company contact:
    Adi Frish
    Senior VP Business Development & Licensing
    RedHill Biopharma
    +972-54-6543-112
    adi
    
    IR contact (U.S.):
    Timothy McCarthy, CFA, MBA
    Managing Director, Relationship Manager
    LifeSci Advisors, LLC
    +1-212-915-2564
    

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  5. The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 clinical study with opaganib in 270 severe COVID-19 patients is planned to be conducted in up to 40 clinical sites across Russia, Italy, the UK and additional countries

    --

    In parallel, a clinical study of opaganib in up to 40 severe COVID-19 patients has been approved by the FDA and is open for recruitment in the U.S.

    TEL-AVIV, Israel and RALEIGH, N.C., June 18, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has submitted Clinical Trial Applications (CTA) with the UK Medicines & Healthcare Products Regulatory Agency (MHRA) and the…

    The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 clinical study with opaganib in 270 severe COVID-19 patients is planned to be conducted in up to 40 clinical sites across Russia, Italy, the UK and additional countries

    --

    In parallel, a clinical study of opaganib in up to 40 severe COVID-19 patients has been approved by the FDA and is open for recruitment in the U.S.

    TEL-AVIV, Israel and RALEIGH, N.C., June 18, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has submitted Clinical Trial Applications (CTA) with the UK Medicines & Healthcare Products Regulatory Agency (MHRA) and the Italian Medicines Agency (AIFA) for a Phase 2/3 clinical study evaluating opaganib (Yeliva®, ABC294640)1 in patients hospitalized with severe SARS-CoV-2 infection, the cause of COVID-19, and pneumonia.

    Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill, said: "We are quickly advancing the preparations for a global, multi-center powered Phase 2/3 study with opaganib for COVID-19. In line with the global shift from a focus on compassionate use programs to adequately controlled clinical studies, our highest priority is on generating robust data in a controlled setting for regulatory purposes. Following our submission of the Clinical Trial Application in Russia last week, we have submitted similar applications in the UK and Italy, and we are looking to expand the study to additional countries and start treating patients soon. This study, along with the ongoing Phase 2a study in the U.S., should allow us to enroll patients faster to evaluate the efficacy of opaganib against COVID-19 and bring this promising therapy one step closer to those who need it."

    The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study is planned to enroll up to 270 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy. The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14. An unblinded futility interim analysis will be conducted when approximately 100 subjects have been evaluated for the primary endpoint.

    The Company currently plans to conduct the study in up to 40 clinical sites across Russia, Italy, the UK and additional countries.

    In parallel, a randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S. is open for recruitment (NCT04414618). This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. This clinical trial is not powered for statistical significance. 

    The Company previously announced encouraging preliminary findings from six COVID-19 patients requiring high-flow supplemental oxygen treated with opaganib in Israel under compassionate use. All six patients analyzed demonstrated pronounced clinical improvement following treatment initiation with opaganib, substantial improvement in biomarkers, including decreased required supplemental oxygen, higher lymphocyte counts and decreased C-reactive protein (CRP) levels. All six patients analyzed were weaned from supplemental oxygen and discharged from the hospital on room air without having to receive mechanical ventilation.

    To date, a total of 141 subjects have been dosed with opaganib in ongoing and completed Phase 1 and Phase 2 clinical studies in oncology indications, in pharmacokinetic studies in healthy volunteers in the U.S., under the existing U.S. Food and Drug Administration (FDA) approved expanded access requests for oncology patients and under the expanded access for COVID-19 patients in Israel, establishing safety and tolerability in humans both in the U.S. and ex-U.S.

    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, inflammatory and gastrointestinal indications. By inhibiting SK2, opaganib blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation.

    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. Several prior pre-clinical studies support the potential role of SK2 in the replication-transcription complex of positive-strand single-stranded RNA viruses, similar to SARS-CoV-2, and its inhibition may potentially inhibit viral replication. 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 received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 1/2a in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. 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. Opaganib is also being evaluated for the treatment of SARS-CoV-2 infection (COVID-19). 

    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.

    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 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-106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. 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 including forward-looking statements regarding the preliminary findings from the treatment of COVID-19 patients with opaganib. The treatment with opaganib in Israel is administered under a compassionate use program in accordance with the Israeli Ministry of Health guidelines. The findings to date are only preliminary, are based on clinical results of a very limited number of patients. There is no guarantee that these patients will continue to show clinical improvement or that other patients will show similar clinical improvement. 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 clinical condition of the patients treated with opaganib will not continue to improve and may worsen, the risk that the U.S. Phase 2a clinical study evaluating opaganib will not be successful; the risk that the Company will not initiate a the Phase 2/3 study in Russia, Italy and the UK and will not expand this study to a multinational study with sites in additional countries, the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement, the risk that clinical trials of opaganib in Israel, the U.S., Russia, Italy, the UK or elsewhere for the treatment of COVID-19, if conducted at all, will not show any improvement in patients, 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 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

    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.

    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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