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RedHill Biopharma Further Expands Opaganib Manufacturing Capacity for COVID-19 with Cosmo Pharmaceuticals


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TEL AVIV, Israel and RALEIGH, N.C., Jan. 28, 2021 /PRNewswire/
 RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ( Cosmo ) to further expand manufacturing capacity for opaganib (Yeliva
®, ABC294640)
[1], to address prospective demand subsequent to potential global emergency use authorizations.
The growing concerns over viral mutations and the spread of new potent and evasive viral strains have increased the dire need for new COVID-19 therapeutics,
said Reza Fathi, PhD., RedHill s Senior VP, R&D. We are very pleased to expand the manufacturing capacity of opaganib with a partner of Cosmo s quality. Opaganib is designed to act broadly against different viral strains irrespective of mutations in the Spike protein. Opaganib is a Phase 2/3-stage novel, orally-administered sphingosine kinase-2 (SK ....

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Redhill further expands opaganib manufacturing capacity for COVID-19 with Cosmo


Credit: RedHill Biopharma
New agreement further expands manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study, progress with the ongoing global Phase 2/3 study, and amid the urgent need to address emerging viral strains
TEL AVIV, Israel and RALEIGH, NC, January 28, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) ( RedHill or the Company ), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ( Cosmo ) to further expand manufacturing capacity for opaganib (Yeliva®, ABC294640) , to address prospective demand subsequent to potential global emergency use authorizations.
The growing concerns over viral mutations and the spread of new potent and evasive viral strains have increased the dire need for new COVID-19 therapeutics. said Reza Fathi, PhD., RedHill s Senior VP, R&D. We are very pleased to expand the manufacturing capacity of opaga ....

Bryan Gibbs , Redhill Biopharma , Falk Gmbh , Reza Fathi , Adi Frish , Davide Malavasi , Cosmo Pharmaceuticals , Us Department Of Defense , Us National Institute Of Health , World Health Organization , Apogee Biotechnology Corp , Redhill Biopharma Ltd , Exchange Commission , Company Annual Report On Form , Company Expanded Access Program , Corporate Business Development , Office Of Orphan Products Development , U Apogee Biotechnology Corp , Safety Monitoring Board , Orphan Drug , Acquired Respiratory Distress , Apogee Biotechnology , Orphan Products , Hill Biopharma , Private Securities Litigation Reform Act , Expanded Access Program ,

RedHill announces positive top-line data from P2 COVID-19 study of opaganib


Credit: RedHill Biopharma
Preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms
Consistent trends demonstrate greater improvement in reducing oxygen requirement by end of treatment at Day 14 in the opaganib-treated arm across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale
The opaganib-treated arm demonstrated a greater improvement in reaching room air within 14 days (52.6% vs. 22.2%); greater improvement in reduction to 50% supplemental oxygen by Day 14 (89.5% vs. 66.7%); a higher proportion of patients discharged by Day 14 (73.7% vs. 55.6%) and a greater reduction in the median total oxygen requirement (AUC) over 14 days (68.0% vs. 46.7%) ....

Bryan Gibbs , Redhill Biopharma , Adi Frish , Markl Levitt , Us Department Of Defense , Us National Institute Of Health , Company Phase , World Health Organization , Apogee Biotechnology Corp , Redhill Biopharma Ltd , Exchange Commission , Company Annual Report On Form , Company Expanded Access Program , Corporate Business Development , Office Of Orphan Products Development , U Apogee Biotechnology Corp , Medical Director , Chief Operating Officer , Safety Monitoring Board , Orphan Drug , Apogee Biotechnology , Orphan Products , Hill Biopharma , Private Securities Litigation Reform Act , Expanded Access Program , Annual Report ,

RedHill Biopharma Announces Positive Top-Line Safety and Efficacy Data from Phase 2 COVID-19 Study of Opaganib


(2)
Preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms
Consistent trends demonstrate greater improvement in reducing oxygen requirement by end of treatment at Day 14 in the opaganib-treated arm across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale
The opaganib-treated arm demonstrated a greater improvement in reaching room air within 14 days (52.6% vs. 22.2%); greater improvement in reduction to 50% supplemental oxygen by Day 14 (89.5% vs. 66.7%); a higher proportion of patients discharged by Day 14 (73.7% vs. 55.6%) and a greater reduction in the median total oxygen requirement (AUC) over 14 days (68.0% vs. 46.7%) ....

Bryan Gibbs , Redhill Biopharma , Adi Frish , Markl Levitt , Us Department Of Defense , Us National Institute Of Health , Company Phase , World Health Organization , Apogee Biotechnology Corp , Redhill Biopharma Ltd , Exchange Commission , Company Annual Report On Form , Company Expanded Access Program , Corporate Business Development , Office Of Orphan Products Development , U Apogee Biotechnology Corp , Prnewswire Redhill Biopharma Ltd , Hill Biopharma , Medical Director , Chief Operating Officer , Safety Monitoring Board , Orphan Drug , Apogee Biotechnology , Orphan Products , Private Securities Litigation Reform Act , Expanded Access Program ,