MHRA issues consent for RedHill Bioharma's Yeliva trial

The UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved RedHill Biopharma's application to carry out a Phase II/III study evaluating Yeliva (opaganib) in patients hospitalised with severe SARS-CoV-2 infection and pneumonia.

Opaganib, a new chemical entity, is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer, anti-inflammatory and anti-viral activities.

The multicentre, randomised, double-blind, parallel-arm, placebo-controlled Phase II/III study is set to enrol up to 270 subjects with severe COVID-19 pneumonia requiring hospitalisation and treatment with supplemental oxygen.

Subjects will be randomised 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.

RedHill is planning to conduct the trial in Italy, the UK, Russia and additional countries.

In parallel,the firm has initiated enrolment for a randomised, double-blind, placebo-controlled Phase IIa clinical study with opaganib in the US, which aims to enrol up to 40 patients with severe COVID-19 pneumonia requiring hospitalisation and supplemental oxygen.