RedHill Biopharma Reports the Submission of CTA for P-II/III Study Evaluating Opaganib Against COVID-19 in Russia
Shots:
- RedHill has submitted CTA with the Ministry of Health of the Russian Federation for a P-II/III clinical study evaluating Yeliva (opaganib, ABC294640)1 in patients hospitalized with severe COVID-19 and pneumonia
- The P-II/III study will assess opaganib vs placebo, on top of SOC and plans to enroll 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygenation. The 1EPs of study will be the proportion of patients requiring intubation and mechanical ventilation by day 14
- An interim analysis will be conducted when ~100 patients have been evaluated for 1EPs. The study will be conducted in clinical sites across Russia and other EU countries. Additionally, RedHill is initiating P-IIa study with opaganib in the US
Click here to read full press release/ article | Ref: Buinesswire | Image: RedHill
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