RedHill Biopharma Ltd (Nasdaq: RDHL), an Israel-based speciality biopharmaceutical company, has collaborated with two United States-based manufacturers for large-scale manufacturing of Opaganib, it was reported on Wednesday.
These partnerships further advance ongoing preparations to support potential emergency use applications for the product intended to treat severe COVID-19 pneumonia expected by the first quarter of 2021.
The product is a novel, orally administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that acts on the cause and effect of COVID-19 disease, aimed at a host cell component involved in viral replication, potentially minimising likelihood of resistance due to viral mutations.
The company has enrolled a total of 270 patients in the global phase two/three study with opaganib in patients with severe COVID-19 pneumonia (NCT04467840) and is more than 50% complete. The study has received approval in six countries and is on schedule to reveal top-line data in the first quarter of 2021. The parallel United States phase two study with the product has completed enrolment of all 40 patients, with top line data expected in the coming weeks.
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