RedHill Biopharma Ltd (RDHL)

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Brazil Approves RedHill Biopharma’s Phase 2/3 COVID-19 Study with Opaganib

GlobeNewswire
RedHill Biopharma Ltd.
,GlobeNewswire•September 22, 2020

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

https://finance.yahoo.com/news/brazil-approves-redhill-biopharma-phase-140000086.html