Opaganib's unique, host-targeted, dual antiviral and anti-inflammatory approach to combatting COVID-19 is expected to maintain effect against other emerging variants
--
The global 475-patient Phase 2/3 study with opaganib oral pill in hospitalized COVID-19 patients has completed treatment and follow up phase, with top-line results upcoming
TEL AVIV, Israel and RALEIGH, NC, August 26, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced preliminary results of a new preclinical study showing strong inhibition by opaganib (ABC294640)[1] of Delta variant replication while maintaining cell viability at relevant concentrations.
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 Delta (Indian) variant. This work adds to the previously reported work that showed opaganib also inhibits Alpha (Washington), Beta (South African) and Gamma (Brazilian) SARS-CoV-2 variants.
"There is growing evidence in support of the possible key role played by sphingosine kinase-2 in the replication of RNA viruses such as SARS-CoV-2, irrespective of mutations at the spike protein. This makes inhibition of this intra-cellular enzyme a promising therapeutic target for treating COVID-19 disease," said Reza Fathi, PhD., RedHill's Senior VP, R&D. "We have now accumulated extensive evidence from our preclinical work of opaganib's potent ability to inhibit SARS-CoV-2 variants of concern, such as Delta, and expect that to extend to new emerging variants. The strong antiviral and anti-inflammatory activities of oral opaganib potentially address both the viral cause and inflammatory effects of COVID-19."
Opaganib, a leading novel small molecule 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 is believed to exert its antiviral effect by selectively inhibiting sphingosine kinase-2 (SK2), a key enzyme produced in human cells that may be recruited by the virus to support its replication. Opaganib's global 475-patient Phase 2/3 study in hospitalized patients with COVID-19 has completed its treatment and follow up phase, and study top-line results are upcoming.
Evaluations of blinded blended intubation and mortality rates from the Phase 2/3 study have been encouraging compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations[2]. Furthermore, the opaganib Phase 2/3 study has also passed four Data Safety Monitoring Board reviews, including a futility review, and extends the total opaganib safety database to more than 460 patients. Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, presented in June at the World Microbe Forum (WMF) 2021. Additionally, encouraging use of opaganib under compassionate use exemption has been experienced in Israel and Switzerland.
