On Oct. 7, 2020, RedHill Biopharma announced that the U.S. Phase 2 study with opaganib (Yeliva, ABC294640)1 in patients hospitalized with severe COVID-19 pneumonia had passed its second pre-scheduled safety review by the independent Safety Monitoring Committee (SMC) with a unanimous recommendation to continue the study without change. The SMC’s recommendation is based on an unblinded analysis of safety data from the first 24 patients treated in the study for at least seven days. The study was 75% enrolled.

The U.S. Phase 2 study with opaganib, ongoing in eight clinical trial sites, is planned to complete enrollment this month, with data expected to follow before the end of this year. The Phase 2 study is not powered for efficacy and is focused on safety evaluation and identifying a signal of efficacy. 

In parallel, the global Phase 2/3 study with opaganib in patients with severe COVID-19 pneumonia is rapidly enrolling across 15 study sites and is on track to enroll up to 270 patients. This study is focused on, and powered for, efficacy evaluation. The study has been approved in the UK, Italy, Russia, Mexico, Brazil and Israel, with further expansion ongoing.