RedHill Biopharma is set to continue the global Phase II/III study of orally administered opaganib (Yeliva, ABC294640) in people hospitalised with severe Covid-19 pneumonia.
A novel chemical entity, opaganib is a proprietary, first-in-class sphingosine kinase-2 (SK2) selective inhibitor.
The latest development follows a unanimous recommendation to progress after a fourth independent Data Safety Monitoring Board (DSMB) safety review.
The recommendation is based on analysis of the unblinded safety data gathered from the first 255 subjects who received the treatment for 14 days, expanding the total opaganib safety database to around 380 subjects.
The randomised, double-blind, parallel-arm, placebo-controlled study of opaganib in severe Covid-19 pneumonia patients needing hospitalisation and supplemental oxygen has so far enrolled over 75% of subjects at around 40 recruiting sites.
According to recently reported top-line safety and efficacy data from the non-powered US Phase II trial in 40 subjects with Covid-19 pneumonia, opaganib plus standard-of-care showed superior improvement in lowering oxygen need by end of treatment on day 14.
RedHill Biopharma medical director Mark Levitt said: “With approximately 380 patients in the opaganib safety database following this positive fourth DSMB review, we are building a clear picture of the safety profile of opaganib.
“Moreover, adding together the positive Phase II data, the successful DSMB futility reviews and the outcomes from compassionate use of opaganib, we look forward with optimism to the reporting of top-line data from the Phase II/III study, which will provide the clearest indication to date of opaganib’s promise in treating Covid-19.”
Furthermore, data showed no material safety differences between the opaganib and placebo, indicating opaganib’s growing safety database.
In a separate development, the Chinese Center for Disease Control and Prevention director Gao Fu said that Chinese Covid-19 vaccines do not have greater protection rates.
“It’s now under consideration whether we should use different vaccines from different technical lines for the immunisation process.”