On Sept. 3, 2020, RedHill Biopharma announced the selection of opaganib, 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 Program. The grant was awarded to RedHill’s partner, Apogee Biotechnology, from whom RedHill licensed opaganib, who will conduct the research being supported by the grant.

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).

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 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, set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen.