RedHill Biopharma Pushes Forward With Yeliva Trials for COVID-19

RedHill Biopharma has announced positive steps in two late-stage trials evaluating its Yeliva (opaganib) for severe COVID-19 patients and said it plans to file an Emergency Use Authorization (EUA) for the drug as early as the end of the year.

The Italian Medicines Agency has approved a global phase 2/3 trial evaluating Yeliva vs. a placebo with standard of care for severe COVID-19 patients requiring hospitalization and supplemental oxygen. The study will enroll 270 patients across 40 clinical sites and has already been approved in the UK, Russia and Mexico (DID, Aug. 13).

Separately, an independent safety monitoring committee has recommended the continuation of another phase 2 trial in the U.S. That trial is evaluating Yeliva vs. a placebo in 40 hospitalized patients with severe COVID-19 who require supplemental oxygen.

RedHill’s Chief Operating Officer Gilead Raday said the company anticipates applying to the FDA for an EUA for opaganib as early as the end of the year, subject to receiving positive data from both trials. — Jordan Williams