Israeli gastrointestinal diseases specialist RedHill Biopharma (Nasdaq: RDHL) says that its US Phase II study of Yeliva (opaganib; ABC294640) in hospitalized patients with severe pneumonia linked to COVID-19, has passed its second pre-scheduled safety review by the independent Safety Oversight Committee (CSI) with a unanimous recommendation to continue the study without change.
The CSI recommendation is based on an unblinded analysis of safety data from the first 24 patients treated in the study for at least seven days. Patient recruitment for the study is 75% complete.
The US study, currently underway at eight clinical trial sites, is expected to complete recruitment this month, with data expected to follow before the end of the year. The Phase II study is not efficacy-oriented and focuses on assessing safety and identifying a signal of efficacy.
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