RedHill to expand study of Yeliva for COVID-19

RedHill Biopharma (NASDAQ:RDHL) has filed an application in Mexico and has initiated an application in Brazil to add sites to its global Phase 2/3 clinical trial evaluating Yeliva (opaganib, ABC294640) on top of standard-of-care treatment in severely ill hospitalized COVID-19 patients with pneumonia.

The 270-subject study was previously approved in Russia and the UK. The primary endpoint will be the proportion of patients requiring intubation and mechanical ventilation by day 14 compared to placebo.

Enrollment in an ongoing Phase 2 study in up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen should be completed next month although it is not powered for statistical significance.

If all goes well, the company believes it may file applications for emergency use in Q4.

https://seekingalpha.com/news/3593547-redhill-to-expand-study-of-yeliva-for-covidminus-19