RedHill Biopharma’s Opaganib COVID-19 Study Passes Second Independent Committee Review
Second pre-scheduled independent Safety Monitoring Committee (SMC) review unanimously recommends continuation without change of the U.S. Phase 2 study with opaganib in COVID-19 -- The U.S. Phase 2 study is 75% enrolled with data expected later this quarter -- In parallel, enrollment advancing rapidly in the global COVID-19 Phase 2/3 study with opaganib -- Global emergency use authorization applications are planned, subject to positive clinical results
TEL AVIV, Israel and RALEIGH, N.C., Oct. 07, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the U.S. Phase 2 study with opaganib (Yeliva®, ABC294640)1 in patients hospitalized with severe COVID-19 pneumonia has passed its second pre-scheduled safety review by the independent Safety Monitoring Committee (SMC) with a unanimous recommendation to continue the study without change. The SMC’s recommendation is based on an unblinded analysis of safety data from the first 24 patients treated in the study for at least seven days. The study is 75% enrolled.
The U.S. Phase 2 study with opaganib (NCT04414618), ongoing in eight clinical trial sites, is planned to complete enrollment this month, with data expected to follow before the end of this year. The Phase 2 study is not powered for efficacy and is focused on safety evaluation and identifying a signal of efficacy.
In parallel, the global Phase 2/3 study with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) is rapidly enrolling across 15 study sites and is on track to enroll up to 270 patients. This study is focused on, and powered for, efficacy evaluation. The study has been approved in the UK, Italy, Russia, Mexico, Brazil and Israel, with further expansion ongoing.
“Passing this second pre-scheduled independent safety review, involving data from 60% of the patients in the study, is an important milestone in the ongoing development of opaganib as a potential therapy for patients with severe COVID-19,” said Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill. “We are rapidly building more data and experience with opaganib, with the safety database from opaganib studies now numbering close to 200 patients. This further supports the ongoing global Phase 2/3 study which is focused on delivering efficacy and is on track to enroll up to 270 patients by the end of the year.”
RedHill is in discussions with U.S. government agencies around potential funding to support the rapid advancement of opaganib toward potential emergency use approval and manufacturing scale-up.
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