RedHill Biopharma Ltd. a specialty biopharmaceutical company, today announced preliminary results of a new preclinical study showing potent inhibition of COVID-19 variants of concern by opaganib (Yeliva, ABC294640.
Opaganib, a leading novel investigational oral pill in development for the treatment of COVID-19, is a unique host-targeted, dual antiviral and anti-inflammatory drug that acts on the cause and effect of COVID-19. It exerts its antiviral effect by selectively inhibiting sphingosine kinase-2 (SK2), a key enzyme produced in human cells that can be recruited by the virus to support its replication. Following the recently presented positive U.S. Phase 2 study data, opaganib’s global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 is fully enrolled and is expected to be completed in the coming weeks.
Working with the University of Louisville Center for Predictive Medicine, opaganib was studied in a 3D tissue model of human bronchial epithelial cells (EpiAirway) to evaluate the in vitro efficacy of opaganib in inhibiting the Beta (South African) and Gamma (Brazilian) SARS-CoV-2 variants. Preliminary results showed potent inhibition of both the Beta and Gamma variants by opaganib at non-cytotoxic doses.
“The results we have seen with opaganib so far are exciting,” said William Severson, Ph.D., Director of Shared Resources for the Center for Predictive Medicine, University of Louisville. “They provide further evidence in support of opaganib’s antiviral capabilities and highlight opaganib’s potential as an orally-administered treatment for COVID-19 and its continuously emerging variants.”
“Opaganib inhibits an enzyme in the COVID-19 patients’ cells called sphingosine kinase-2, which the SARS-CoV-2 virus can recruit in order to replicate,” said Reza Fathi, PhD., RedHill’s Senior VP, R&D. “Opaganib’s dual antiviral and anti-inflammatory mechanism of action is independent of mutations in the spike protein. This means we expect opaganib to similarly work against other emerging COVID-19 variants, including the Delta (Indian) variant. Moreover, we are looking forward to seeing the top-line clinical data from the global Phase 2/3 study which is expected to be completed in the coming weeks.”
The global Phase 2/3 study of opaganib in COVID-19 has previously received four independent DSMB recommendations to continue following unblinded safety reviews and a futility review. Additionally, an evaluation of the blinded blended intubation and mortality rates to date was encouraging as compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations.