RedHill posts positive data from phase 2 COVID-19 study of Opaganib

 

• RedHill Biopharma (RDHL +3.2% announces preliminary data from the non-powered U.S. Phase 2 study of 40 hospitalized patients shows that orally-administered opaganib was safe, with no material safety differences between opaganib and control arms.
• The study aimed to evaluate safety and identify preliminary signs of activity. Patients in the study were randomized at a 1:1 ratio to receive either Opaganib or placebo on top of standard-of-care ((SoC)) and were followed up for up to 42 days post treatment initiation.
• Full analysis of the data, including viral and inflammatory biomarker analyses, baseline risk factors and SoC background therapy stratifications, is expected in the coming weeks.
• Top-line data from the global Phase 2/3 COVID-19 study in 270 hospitalized patients is expected in Q1 of 2021.
• "We continue to work diligently to compile a robust data set to support potential filing of global emergency use applications," Mark Levitt, Medical Director at RedHill said.
• https://seekingalpha.com/news/3648078-redhill-posts-positive-data-from-phase-2-covidminus-19-study-of-opaganib