RedHill Biopharma (NASDAQ:RDHL) Ltd. has announced results of a new preclinical study demonstrating strong inhibition by its investigational oral pill opaganib (ABC294640) of the coronavirus (COVID-19) Delta variant replication while maintaining cell viability at relevant concentrations.
Working with the University of Louisville Center for Predictive Medicine, the company noted that 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. RedHill said this adds to the previously reported work that showed opaganib also inhibits 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 Dr Reza Fathi, RedHill's Senior VP, R&D.
READ: RedHill Biopharma completes treatment and follow-up in the 475-patient global Phase 2/3 COVID-19 study with opaganib
"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," he added.
The global 475-patient Phase 2/3 study with orally-administered opaganib 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.
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 US Phase 2 data in patients with severe COVID-19, presented in June at the World Microbe Forum (WMF) 2021.
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.
RedHill Biopharma (NASDAQ:RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.
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