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- RedHill Biopharma (NASDAQ:RDHL) announced that its oral COVID-19 therapy opaganib “significantly” improved viral clearance in a Phase 2/3 trial involving severely ill hospitalized patients with the disease.
- In patients with positive PCR at screening, the median time to viral RNA clearance with opaganib improved by at least four days. In the opaganib arm, the median for viral clearance was ten days, while the placebo arm did not reach the clearance median by the end of the 14-day treatment. (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463).
- With a median of 11-days from the onset of symptoms, the patient group was much further advanced than the mild-to-moderate outpatients for whom the currently FDA authorized COVID-19 therapies are indicated.
- In July, RedHill (RDHL) announced the completion of treatment and follow-up in the 475-patient Phase 2/3 study for opaganib.