Benzinga | Feb 23, 2021 07:08AM EST

RedHill Biopharma Announces Planned Expansion Of Opaganib Global Phase 2/3 COVID-19 Study To The US

TEL AVIV, Israel and RALEIGH, NC, Feb. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced its plans to expand the Company's global Phase 2/3 study of opaganib[1] in patients with severe COVID-19 to the U.S., following U.S. Food and Drug Administration (FDA) review of the data from the U.S. Phase 2 study of opaganib and receipt of its recommendations.

Expansion of the global Phase 2/3 study to the U.S. will entail adjustments to the protocol based on the FDA's recommendations and ongoing discussions. The expansion of the study to the U.S. will help further speed-up enrollment, expanding the study to a total of 8 countries and approximately 40 recruiting sites, with additional sites and countries being added. The 464-patient study is over 50% enrolled and is expected to deliver top-line data in the second quarter of 2021.

The global Phase 2/3 study recently underwent a positive DSMB futility review, which is suggestive that the study has the potential for a positive outcome. RedHill recently announced positive top-line safety and efficacy data from the non-powered U.S. Phase 2 study with opaganib in patients with COVID-19 pneumonia, in which opaganib demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14 across key primary and secondary efficacy outcomes. The Phase 2 data also showed no material safety differences between the opaganib and placebo treatment arms - further adding to the growing safety database for opaganib.

Opaganib is a novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity, that targets a human cell component involved in viral replication and is therefore expected to be effective against emerging viral variants with mutations in the spike protein.