Policy & Regulation
RedHill's preliminary top-line data from opaganib study in hospitalized COVID-19 patients with pneumonia did not meet primary endpoint
15 September 2021 -

Biopharmaceutical company RedHill Biopharma Ltd (Nasdaq:RDHL) said on Tuesday that the preliminary top-line data from the 475-patient global Phase 2/3 study with opaganib in hospitalized patients with severe COVID-19 pneumonia did not meet its primary endpoint.

The company added that the multi-centre, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study enrolled 475 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.

Subjects were randomized at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy. The primary endpoint of the company's study is the proportion of patients breathing room air without oxygen support by Day 14. Analysis of the study efficacy endpoints did show trends in favor of the opaganib arm vs. placebo across multiple endpoints.

These findings, together with preliminary analysis pointing to increased benefit in a subset of patients requiring less oxygen, could support the potential utilization of opaganib in earlier stages of the disease and are in line with the results from the company's US Phase 2 study.

Analysis of the top-line data is ongoing, including an analysis of the potential for increased benefit of treatment with opaganib in patients at earlier stages of disease. The company plans to discuss the data with the U.S. FDA and foreign regulators, to help determine next steps.

Opaganib (ABC294640), which is a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta, concluded the company.