RedHill Biopharma Ltd. (RDHL) said the mid/late stage study of its Covid-19 drug candidate, Opaganib passed fourth review by an independent Data Safety Monitoring Board (DSMB).
Following the analysis of safety data from the first 255 patients of total 380, treated with Opaganib for 14 days, the company received unanimous recommendation from DSMB to continue the Phase 2/3 study of orally-administered opaganib in severe Covid-19 pneumonia.
Redhill said a 464-patient global Phase 2/3 study of Opaganib in Covid-19 is going on.
"Adding together the positive Phase 2 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 2/3 study, which will provide the clearest indication to date of opaganib's promise in treating COVID-19," Mark L. Levitt, Medical Director at RedHill, said.
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