RDHL Redhill Biopharma Ltd.

10.09
+0.11  (+1%)
Previous Close 9.98
Open 9.81
52 Week Low 3.2621
52 Week High 11.35
Market Cap $377,452,814
Shares 37,408,604
Float 37,408,604
Enterprise Value $307,370,353
Volume 153,345
Av. Daily Volume 442,533
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Upcoming Catalysts

Drug Stage Catalyst Date
Opaganib
COVID-19
Phase 2/3
Phase 2/3
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Opaganib
COVID-19
Phase 2a
Phase 2a
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Drug Pipeline

Drug Stage Notes
RHB-204
Nontuberculous mycobacteria (NTM) infections
Phase 3
Phase 3
Phase 3 trial to be initiated.
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. 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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  2. 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.

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  3. 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 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 or the development of a commercial companion diagnostic for the detection of Mycobacterium avium subspecies paratuberculosis (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 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 experiences 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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  4. Opaganib completely inhibited SARS-CoV-2 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
    --
    Opaganib is uniquely positioned as an orally-administered potential COVID-19 treatment combining potent antiviral and anti-inflammatory mechanisms of action, targeting a host cell component and minimizing likelihood of resistance
    --
    Global Phase 2/3 and U.S. Phase 2 clinical studies ongoing with opaganib for severe COVID-19 pneumonia 
    --
    RedHill's second COVID-19 drug candidate, RHB-107 (upamostat), a novel serine protease inhibitor, strongly inhibited SARS-CoV-2 viral replication in the same model, further supporting planned initiation

    Opaganib completely inhibited SARS-CoV-2 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

    --

    Opaganib is uniquely positioned as an orally-administered potential COVID-19 treatment combining potent antiviral and anti-inflammatory mechanisms of action, targeting a host cell component and minimizing likelihood of resistance

    --

    Global Phase 2/3 and U.S. Phase 2 clinical studies ongoing with opaganib for severe COVID-19 pneumonia 

    --

    RedHill's second COVID-19 drug candidate, RHB-107 (upamostat), a novel serine protease inhibitor, strongly inhibited SARS-CoV-2 viral replication in the same model, further supporting planned initiation of a Phase 2/3 U.S. outpatient study later this year

           

    TEL AVIV, Israel and RALEIGH, N.C., Sept. 08, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that opaganib1 demonstrated potent inhibition of SARS-CoV-2, the virus that causes COVID-19, achieving complete blockage of viral replication in an in vitro model of human lung bronchial tissue. Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and anti-viral activity that targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance. Opaganib is currently being evaluated in global Phase 2/3 and U.S. Phase 2 clinical studies for the treatment of severe COVID-19 pneumonia.

    Working in collaboration with the University of Louisville Center for Predictive Medicine, opaganib was studied in a 3D tissue model of human bronchial epithelial cells (EpiAirway) which morphologically and functionally resembles the human airway and is similar to the model used to discover SARS-CoV-22. This study was designed to evaluate the in vitro efficacy of opaganib in inhibiting SARS-CoV-2 infection and included a positive control of remdesivir, a drug with known antiviral activity.

    Results from this study showed a clear and compelling antiviral effect of opaganib against SARS-CoV-2. Opaganib demonstrated the most potent activity compared to all compounds tested, including the positive control, remdesivir. Treatment of cells infected with SARS-CoV-2 resulted in a dose-dependent inhibition of virus production without compromising cell membrane integrity, a measure of cell viability and drug safety, further demonstrating opaganib's promising potential for treating patients with COVID-19.

    A graphic accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e60ced55-ca9d-4648-81cb-907be7571136

    Opaganib at 1mg/ml (a pharmacologically relevant concentration) completely inhibited viral replication as measured after three days of incubation. This potent opaganib activity compares favorably with remdesivir data as the active control in the RedHill study which is consistent with published remdesivir data3.  Data from the study is planned to be submitted to a peer-reviewed journal.

    "Opaganib's previously demonstrated anti-inflammatory activity, combined with our now proven specific anti-SARS-CoV-2 viral activity, provides a unique dual mechanism of action with the potential to greatly benefit COVID-19 patients by inhibiting the key drivers of disease progression - viral replication and lung inflammation," said Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill. "These compelling data, using a physiologically relevant human respiratory tissue model, demonstrate opaganib's potential to strongly inhibit SARS-CoV-2 viral replication, validating the hypotheses underlying our ongoing global Phase 2/3 and U.S. Phase 2 clinical studies and further supporting their rationale. Accordingly, we are accelerating progress toward our goal of generating a robust data package to potentially support emergency use authorizations for COVID-19." 

    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 recently received approval in Israel and has been approved in the United Kingdom, Italy, Russia and Mexico, with further expansion progressing.

    In parallel, the randomized, double-blind, placebo-controlled U.S. Phase 2 study (NCT04414618) with opaganib in patients with severe COVID-19 pneumonia is more than 50% 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.

    In addition to opaganib, RedHill's in-vitro study evaluated the antiviral activity of its Phase-2 stage investigational drug, RHB-107 (upamostat), a serine protease inhibitor active against a number of human serine proteases, with results demonstrating potent inhibition of SARS-CoV-2 viral replication. A U.S. Phase 2/3 study with RHB-107 in an outpatient setting is planned to be initiated later this year.

    "Host cellular proteases play a critical role in the process of SARS-CoV-2 entry into cells, specifically responsible for activating the SARS-CoV-2 spike (S) protein, which is a prerequisite for the fusion of viral and host cell membranes during viral entry," said Terry F. Plasse MD, Medical Director at RedHill. "RHB-107 demonstrated excellent antiviral activity, with viral replication being strongly inhibited in a dose-dependent manner at pharmacologically relevant concentrations. As with opaganib, RHB-107 (upamostat) is orally bioavailable and therefore potentially suitable for both inpatient and out-patient settings."

    The results from the preclinical studies of opaganib and RHB-107 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 of the data and potentially supportive experiments.  

    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 coronavirus (COVID-19).

    Preclinical data have demonstrated both anti-inflammatory and antiviral activities of opaganib, with the potential to reduce lung inflammatory 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 studies4 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 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 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 infection. 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 diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults5, Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults6, and Aemcolo® for the treatment of travelers' diarrhea in adults7. 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.

    The results from the preclinical studies of opaganib and RHB-107 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 of the data and potentially supportive experiments. Such review and analysis may result in findings inconsistent with the results disclosed in this release and may not be replicated in future pre-clinical or clinical trials.  Accordingly,  investors should not rely on the results described in this release as definitive proof of the antiviral effect of opaganib against SARS-CoV-2 and whether in fact opaganib will be an effective treatment of SARS-CoV-2.

    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 RHB-107 will not be successful, if conducted at all; the risk the antiviral activity in the in vitro study will not be demonstrated in clinical trials; the risk of a delay in receiving data to support applying for 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 in additional countries and that it will not be successful; the risk that the Company will not initiate the Phase 2/3 study in COVID-19 with RHB-107 or that it will be delayed;  the risk that other COVID-19 patients treated with opaganib will not show any clinical improvement; the risk that clinical trials with opaganib in 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; 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 or the development of a commercial companion diagnostic for the detection of Mycobacterium avium subspecies paratuberculosis (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 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 (Yeliva®, ABC294640) is an investigational new drug, not available for commercial distribution.

    2 Na Zhu et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med 2020;382:727-33.

    3 Pruijssers AJ et al. Remdesivir Inhibits SARS-CoV-2 in Human Lung Cells and Chimeric SARS-CoV Expressing the SARS-CoV-2 RNA Polymerase in Mice. Cell Reports. Vol 32, Issue 3, 107940, July 21, 2020.

    4 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.

    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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  5. A global Phase 2/3 study in up to 270 patients hospitalized with severe COVID-19 pneumonia, and a U.S. Phase 2 study in up to 40 patients, are ongoing with opaganib, a novel, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and anti-viral properties

    Opaganib has been selected for a grant from Pennsylvania's COVID-19 Vaccines, Treatments and Therapies Program, which supports the rapid advancement of promising novel COVID-19 therapies

    TEL AVIV, Israel and RALEIGH, N.C., Sept. 03, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the selection of opaganib1, a proprietary, first-in-class, orally-administered…

    A global Phase 2/3 study in up to 270 patients hospitalized with severe COVID-19 pneumonia, and a U.S. Phase 2 study in up to 40 patients, are ongoing with opaganib, a novel, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and anti-viral properties

    Opaganib has been selected for a grant from Pennsylvania's COVID-19 Vaccines, Treatments and Therapies Program, which supports the rapid advancement of promising novel COVID-19 therapies

    TEL AVIV, Israel and RALEIGH, N.C., Sept. 03, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the selection of opaganib1, a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor being evaluated for the treatment of severe COVID-19 pneumonia, to receive a $300,000 grant from the State of Pennsylvania's COVID-19 Vaccines, Treatments and Therapies (CV-VTT) Program, which is designed to support rapid advancement of novel COVID-19 therapies. The grant was awarded to RedHill's partner, Apogee Biotechnology Corporation, from whom RedHill licensed opaganib, who will conduct the research being supported by the grant.

    "We are pleased that the State of Pennsylvania has recognized the promising potential of our Phase 2/3-stage drug candidate opaganib as a much-needed therapeutic option for patients with COVID-19," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "This grant will help accelerate and expand the development of opaganib toward our goal of generating a robust data package to potentially support emergency use applications for COVID-19."

    The CV-VTT grant from the State of Pennsylvania will cover key preclinical mechanistic research to further elucidate opaganib's potential role in suppressing the extent and/or duration of COVID-19-related acute respiratory distress syndrome (ARDS).

    To date, the global Phase 2/3 study evaluating opaganib for the treatment of COVID-19 has been approved in the United Kingdom, Italy, Russia, and Mexico, with patient enrollment ongoing and further expansion planned. The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study (NCT04467840) is set to enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.

    The U.S. Phase 2 clinical study with opaganib, running in parallel to the global Phase 2/3 study, is more than 50% 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 next pre-scheduled safety review is scheduled to take place once 24 patients complete seven days of treatment. The study, which is not powered for statistical significance, is a randomized, double-blind, placebo-controlled study (NCT04414618), set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen.

    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 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.

    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 Phase 2/3 program for the treatment of coronavirus (COVID-19). 

    Results from the treatment of the first patients with severe COVID-19 with opaganib have recently been published2. Analysis of treatment outcomes in five patients with severe COVID-19 showed 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.

    Preclinical 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 preclinical 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. 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.

    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 and is also being evaluated for COVID-19. 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 receiving data to support applying for 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 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 that clinical trials with opaganib in 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; 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 or the development of a commercial companion diagnostic for the detection of Mycobacterium avium subspecies paratuberculosis (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 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 experiences 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 (Yeliva®, ABC294640) 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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