A pre-scheduled independent Safety Monitoring Committee (SMC) has recommended that the U.S. Phase 2 COVID-19 study with opaganib continue with no changes; the study is more than 50% enrolled and enrollment is planned to be completed in the coming weeks
The global Phase 2/3 COVID-19 study with opaganib, being conducted in parallel to the U.S. Phase 2 study, received approval in Italy; this study has also been approved in the UK, Russia and Mexico, and is under review in additional countries
The first patients have been enrolled in the global Phase 2/3 study with opaganib, which is set to enroll up to 270 patients hospitalized with severe COVID-19 pneumonia across up to 40 clinical sites
Potential submission of global emergency use applications as early as Q4/2020
TEL AVIV, Israel and RALEIGH, N.C., Aug. 27, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that its U.S. Phase 2 study with opaganib (Yeliva®, ABC294640)1 in patients hospitalized with severe COVID-19 pneumonia, has successfully passed the first scheduled independent Safety Monitoring Committee (SMC) review. The SMC reviewed unblinded safety data from the first 12 patients treated for at least seven days, recommending that the study continue without change. The study is more than 50% enrolled and enrollment is expected to be completed in the coming weeks. The next scheduled SMC review will take place once 24 patients complete at least seven days of treatment.
The Company also announced it has received approval from the Italian Medicines Agency (AIFA) for its Clinical Trial Authorization (CTA) application for the global Phase 2/3 study evaluating opaganib in patients hospitalized with severe COVID-19 pneumonia, for which patient enrollment has already commenced.
“The independent SMC’s recommendation to continue the U.S. Phase 2 COVID-19 study without changes is another important step in advancing opaganib as a potential therapy for patients with severe COVID-19. The SMC recommendation further validates the general safety database that we have from treating patients with opaganib, which now numbers more than 140,” said Gilead Raday, RedHill’s Chief Operating Officer. “In parallel, enrollment of the first patients in our global Phase 2/3 study, together with approval for the study in Italy, are additional encouraging steps in our efforts to provide patients with an urgently needed treatment option. Subject to positive data from the studies, we aim to apply for emergency use authorizations as early as the fourth quarter of this year.”
To date, the global Phase 2/3 study has been approved in the UK, Italy, Russia and Mexico, with review ongoing in additional countries 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. Subjects are randomized at a 1:1 ratio to receive either opaganib or placebo, in addition to 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 by an independent data safety monitoring board (DSMB) when approximately 100 subjects have been evaluated for the primary endpoint.
The U.S. Phase 2 clinical study with opaganib, 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.