RedHill Biopharma progresses opaganib in COVID-19 testing

Israel-based biotech RedHill Biopharma (Nasdaq: RDHL) has submitted a Clinical Trial Application (CTA) with the Ministry of Health of the Russian Federation for a Phase II/III clinical study evaluating opaganib (trade name Yeliva) in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia.

“We are moving rapidly to advance our development program with opaganib for COVID-19. We are expanding the development program to Russia and additional countries, in parallel with the US clinical study, in order to accelerate the collection of robust data on the potential efficacy of opaganib against COVID-19,” commented RedHill medical director Dr Mark Levitt.

The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase II/III study is planned to enroll 270 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygenation. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, on top of 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 interim analysis will be conducted when approximately 100 subjects have been evaluated for the primary endpoint.