RedHill Biopharma Reports Results of Opaganib in P-II/III Study for the Treatment of Severe COVID-19
Shots:
- The P-II/III study evaluates opaganib + SoC vs PBO + SoC in patients with sev. COVID-19. The company plans for EUA & MAA in H1’22 & data submissions initiated in Q4’21 in the US, EU, UK & other countries
- In 1st pre-specified analysis, patients with remdesivir & corticosteroids at baseline showed 70.2% mortality benefit with a mortality rate (6.98% vs 23.4%) by Day 42. In 2nd analysis, 34% benefit in time to recovery by Day 14, patients achieved this event (37.4% vs 27.9) & improved median time to viral RNA clearance
- In a post-hoc analysis, 62% reduction in mortality, improved outcomes in time to room air, a median time to hospital discharge & likelihood of intubation & mechanical ventilation
Ref: PR Newswire | Image: Redhill Bio
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