The independent Safety Monitoring Committee (SMC) has completed review for RedHill Biopharma’s (NASDAQ:RDHL) of opaganib (Yeliva) in Phase 2 study, in patients hospitalized with severe COVID-19 pneumonia and recommended that the study continue unmodified.
The SMC reviewed unblinded safety data from the first 12 patients treated for at least seven days.
Phase 2 study is more than 50% enrolled and enrollment is expected to complete in the coming weeks.
Next scheduled SMC review will take place once 24 patients complete at least seven days of treatment.
It also received approval from the Italian Medicines Agency for its Clinical Trial Authorization application for the global Phase 2/3 study, evaluating opaganib in patients hospitalized with severe COVID-19 pneumonia. Subject to positive data, the company aims to apply for emergency use authorizations as early as next quarter.
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