SPY362.06-1.61 -0.44%
DIA296.62-2.62 -0.88%
IXIC12,198.74-7.11 -0.06%

RedHill Announces Unanimous DSMB Recommendation To Continue Phase 2/3 COVID-19 Study With Opaganib

Pre-scheduled independent Data and Safety Monitoring Board (DSMB) unanimously recommends continuation of the global Phase 2/3 study of orally administered opaganib in severe COVID-19 pneumonia Enrollment in the

· 11/19/2020 07:01

Pre-scheduled independent Data and Safety Monitoring Board (DSMB) unanimously recommends continuation of the global Phase 2/3 study of orally administered opaganib in severe COVID-19 pneumonia
Enrollment in the 270-patient global Phase 2/3 COVID-19 study with opaganib is more than 50% complete
Enrollment completed in the parallel U.S. Phase 2 study evaluating opaganib's safety and initial efficacy signal in 40 hospitalized patients with severe COVID-19 pneumonia - data expected in the coming weeks
Emergency use authorization applications planned as early as Q1/2021
Opaganib's mechanism of action potentially minimizes likelihood of resistance due to viral mutations

TEL AVIV, Israel and RALEIGH, N.C., Nov. 19, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the global Phase 2/3 study with opaganib (Yeliva®, ABC294640)[1] in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a pre-scheduled safety review by an independent Data and Safety Monitoring Board (DSMB). The DSMB's recommendation is based on an unblinded analysis of safety data from the first 70 patients treated for 14 days.