RedHill Biopharma to expand COVID-19 opaganib trial to US

pharmafile | February 24, 2021 | News story | Research and Development COVID-19, RedHill Biopharma 

RedHill Biopharma has announced its plans to expand the company’s global Phase II/III study of opaganib in patients with severe COVID-19 to the US.

The move follows the FDA’s review of both data from the US Phase II study of the drug and its recommendations.

Opaganib is a novel, orally-administered sphingosine kinase-2 inhibitor with preclinically demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity. The drug’s target is 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 of coronavirus.

Expanding the global Phase II/III study to the US will entail adjustments to the protocol based on the FDA’s recommendations and ongoing discussions. The expansion will help expedite trial enrolment, increasing the study’s reach to a total of 8 countries and approximately 40 recruiting sites, with additional sites and countries being added. The 464-patient trial is over halfway enrolled, and is expected to deliver top-line data in the second quarter of this year.

The global Phase II/III study recently underwent a positive independent Data Safety Monitoring Board (DSMB) futility review, which saw the board recommended the study continue.

RedHill recently announced positive top-line safety and efficacy data from the non-powered US Phase II study with opaganib in patients with COVID-19 pneumonia, in which the drug demonstrated greater improvement in reducing oxygen requirement by end of treatment on day 14 across key primary and secondary efficacy outcomes. The Phase II data also showed no material safety differences between the opaganib and placebo treatment arms.

Darcy Jimenez

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