#RDHL announced that the "U.S. Phase 2 study with opaganib (Yeliva®, ABC294640)1 in patients hospitalized with severe COVID-19 pneumonia has 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 is 75% enrolled.
The U.S. Phase 2 study with opaganib (NCT04414618), 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 (NCT04467840) 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" (see press release HERE).
Second pre-scheduled independent Safety Monitoring Committee (SMC) review unanimously recommends continuation without change of the U.S.Phase 2 study with opaganib in COVID-19
The U.S.Phase 2 study is 75% enrolled with data expected later this quarter
Global emergency use authorization applications are planned, subject to positive clinical results
Learn more about RedHill Biopharma’s Opaganib at our AmpCard.