RedHill Biopharma Expands Opaganib Manufacturing Capacity For COVID-19 With Cosmo Pharma

(RTTNews) - RedHill Biopharma Ltd. (RDHL) said that it has reached an agreement with Cosmo Pharmaceuticals to further expand manufacturing capacity for orally-administered opaganib following positive top-line data from its Phase 2 COVID-19 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.

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.

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 ordinal scale.