Redhill BioPharma Nabs Mexican Approval for Phase 2/3 Trial of Yeliva for COVID-19

Mexico’s drug regulators have approved RedHill Biopharma’s planned phase 2/3 trial of Yeliva (opaganib) in hospitalized COVID-19 patients with pneumonia.

The study aims to enroll 270 participants who will either receive Yeliva or a placebo along with the standard of care to assess the share of patients requiring intubation and mechanical ventilation by day 14.

The global study has previously been approved in Russia and the UK and is awaiting approval in Italy and Brazil.  

RedHill also plans to complete enrollment of a phase 2 U.S. trial of Yeliva for severe COVID-19 patients this month. That trial is only expected to enroll up to 40 hospitalized patients with pneumonia who are receiving supplemental oxygen.

The company said it expects to submit global emergency use applications for Yeliva as a COVID-19 treatment as early as the fourth quarter of 2020. — Jordan Williams