On Aug. 27, 2020, RedHill Biopharma announced that its U.S. Phase 2 study with opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia, had successfully passed the first scheduled independent Safety Monitoring Committee (SMC) review.

The Company also announced it had received approval from the Italian Medicines Agency (AIFA) for its Clinical Trial Authorization (CTA) application for the global Phase 2/3 study evaluating opaganib in patients hospitalized with severe COVID-19 pneumonia, for which patient enrollment has already commenced.

To date, the global Phase 2/3 study has been approved in the UK, Italy, Russia and Mexico, with review ongoing in additional countries and further expansion planned. The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study (NCT04467840) is set to enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects are randomized at a 1:1 ratio to receive either opaganib or placebo, in addition to 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 by an independent data safety monitoring board (DSMB) when approximately 100 subjects have been evaluated for the primary endpoint.

The U.S. Phase 2 clinical study with opaganib, which is not powered for statistical significance, is a randomized, double-blind, placebo-controlled study (NCT04414618), set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen.