RedHill Biopharma Ltd. announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Company’s Clinical Trial Authorization application to commence a Phase II/III study evaluating Yeliva (opaganib) in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia. RedHill has also submitted CTA applications for this study in Russia and Italy and plans to expand the study to additional countries.
The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase II/III study is set to enroll up to 270 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy. The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14. An unblinded futility only interim analysis will be conducted by an independent data safety monitoring board (DSMB) when approximately 100 subjects have been evaluated for the primary endpoint. The study is planned to be conducted in clinical sites across Italy, the UK, Russia and additional countries.
In parallel, RedHill has initiated enrollment for a randomized, double-blind, placebo-controlled Phase IIa clinical study with opaganib in the U.S. (NCT04414618). This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. This clinical trial is not powered for statistical significance.