RedHill Biopharma expands manufacturing capacity of Opaganib for COVID-19 with Cosmo Pharma

New pact enhances manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 study, progress with the ongoing global Phase 2/3 study, and amid the urgent need to address emerging viral strains

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RedHillRedHill Biopharma Ltd has announced a manufacturing agreement with Cosmo Pharmaceuticals NV.

According to the specialty biopharmaceutical company, the partnership is to further expand manufacturing capacity for opaganib (Yeliva®, ABC294640), to address prospective demand subsequent to potential global emergency use authorizations.

Reza Fathi, PhD., RedHill’s Senior VP, R&D, said, “The growing concerns over viral mutations and the spread of new potent and evasive viral strains have increased the dire need for new COVID-19 therapeutics.”

Fathi added: “We are very pleased to expand the manufacturing capacity of opaganib with a partner of Cosmo’s quality. Opaganib is designed to act broadly against different viral strains irrespective of mutations in the Spike protein. Opaganib is a Phase 2/3-stage novel, orally-administered sphingosine kinase-2 (SK2) inhibitor with demonstrated antiviral, anti-inflammatory, and anti-thrombotic activity.

By targeting SK2, a human cell component involved in viral replication irrespective of mutations in the viral Spike protein, opaganib potentially addresses the emergence of new strains.”

Davide Malavasi, Cosmo’s Head of Manufacturing, said, “We are delighted to further strengthen our partnership with RedHill on expanded opaganib manufacturing, and to play a part in trying to help alleviate the suffering the coronavirus pandemic is causing across the world, should opaganib be approved for use.”

Global study

The global Phase 2/3 study of opaganib in severe COVID-19 pneumonia (NCT04467840) is ongoing, with patients enrolled in more than 30 sites in multiple countries.

In the days to come, an interim independent Data and Safety Monitoring Board (DSMB) futility analysis will be conducted, evaluating data from the first 135 subjects that have reached the primary endpoint. The study has previously undergone two unblinded independent DSMB safety data reviews, with unanimous recommendations to continue the study.

(With inputs from The OnLook News Research Bureau)

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