Thursday, November 26, 2020
RedHill Biopharma Ltd., a specialty biopharmaceutical company, today announced partnerships with two leading, U.S.-based manufacturers for large-scale manufacturing of opaganib. These collaborations further advance ongoing preparations to support potential emergency use applications for opaganib to treat severe COVID-19 pneumonia, expected as early as the first quarter of 2021. The new collaborations follow recently announced collaborations with European and Canadian manufacturers.
"We are expanding our U.S.-based manufacturing capacity for orally administered opaganib, ahead of potential emergency use applications as early as Q1/2021," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "Together with our recently announced similar partnerships in Europe and Canada and in light of our rapidly progressing Phase 2/3 opaganib COVID-19 program, these new U.S. partnerships better place RedHill to meet potential demand for opaganib, if approved."
Opaganib is a novel, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that acts on the cause and effect of COVID-19 disease, targeting a host cell component involved in viral replication, potentially minimizing likelihood of resistance due to viral mutations.
Enrollment in the 270-patient global Phase 2/3 study with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) is more than 50% complete. The study is approved in six countries and is on track to deliver top-line data in the first quarter of 2021. This study is focused on and powered for efficacy evaluation, and recently received a unanimous recommendation to continue by an independent Data and Safety Monitoring Board (DSMB), following a pre-scheduled safety review of the first 70 patients to have been treated for 14 days. A prescheduled, unblinded futility interim analysis will also be conducted by the DSMB in the coming weeks, evaluating data from the first 135 subjects that have reached the primary endpoint.
The parallel U.S. Phase 2 study with opaganib (NCT04414618) has completed enrollment of all 40 subjects, with topline data expected in the coming weeks. This study is not powered for efficacy and is focused on safety evaluation and identification of efficacy signals.