A global Phase 2/3 study in up to 270 patients hospitalized with severe COVID-19 pneumonia, and a U.S. Phase 2 study in up to 40 patients, are ongoing with opaganib, a novel, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with dual anti-inflammatory and anti-viral properties
Opaganib has been selected for a grant from Pennsylvania’s COVID-19 Vaccines, Treatments and Therapies Program, which supports the rapid advancement of promising novel COVID-19 therapies
TEL AVIV, Israel and RALEIGH, N.C., Sept. 03, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced the selection of opaganib1, a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor being evaluated for the treatment of severe COVID-19 pneumonia, to receive a $300,000 grant from the State of Pennsylvania’s COVID-19 Vaccines, Treatments and Therapies (CV-VTT) Program, which is designed to support rapid advancement of novel COVID-19 therapies. The grant was awarded to RedHill’s partner, Apogee Biotechnology Corporation, from whom RedHill licensed opaganib, who will conduct the research being supported by the grant.
“We are pleased that the State of Pennsylvania has recognized the promising potential of our Phase 2/3-stage drug candidate opaganib as a much-needed therapeutic option for patients with COVID-19,” said Reza Fathi, PhD., RedHill’s Senior VP, R&D. “This grant will help accelerate and expand the development of opaganib toward our goal of generating a robust data package to potentially support emergency use applications for COVID-19.”
The CV-VTT grant from the State of Pennsylvania will cover key preclinical mechanistic research to further elucidate opaganib’s potential role in suppressing the extent and/or duration of COVID-19-related acute respiratory distress syndrome (ARDS).
To date, the global Phase 2/3 study evaluating opaganib for the treatment of COVID-19 has been approved in the United Kingdom, Italy, Russia, and Mexico, with patient enrollment ongoing 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.
The U.S. Phase 2 clinical study with opaganib, running in parallel to the global Phase 2/3 study, is more than 50% 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 next pre-scheduled safety review is scheduled to take place once 24 patients complete seven days of treatment. The study, 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.