RedHill Biopharma, a specialty biopharmaceutical company, has formed a manufacturing agreement with Cosmo Pharmaceuticals to further expand manufacturing capacity for opaganib to address prospective demand subsequent to potential global emergency use authorizations.
 
“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,” said Reza Fathi, senior vice president, R&D, RedHill. “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, head of manufacturing, Cosmo, 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.”
 
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. An interim independent Data and Safety Monitoring Board (DSMB) futility analysis will be conducted in the coming days, 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.
 
Preliminary data from a non-powered U.S. Phase 2 study of 40 hospitalized patients recently showed that opaganib was safe and demonstrated greater improvement in reducing oxygen requirement by end of treatment on Day 14 across key primary and secondary efficacy outcomes, correlating with clinical improvement as defined by the World Health Organization (WHO) ordinal scale.