Redhill Biopharma has announced partnerships with two specialist pharmaceutical manufacturers in Europe and Canada to increase manufacturing for its COVID-19 candidate opaganib.
Opaganib is currently in global phase II/III and US phase II studies for severe COVID-19 pneumonia, to support potential emergency use applications.
The drug is an oral sphingosine kinase-2 (SK2) selective inhibitor which has previously demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component to potentially minimise the likelihood of viral resistance.
“In light of the rapid progress of our phase II/III COVID-19 development program with opaganib, we are expanding manufacturing capabilities and capacity for opaganib with trusted and high-quality partners, to meet likely demand ahead of potential global emergency use applications,” said Reza Fathi, senior vice president, R&D at RedHill.
The ongoing US phase II study of opaganib is being carried out in eight clinical trials sites and is approaching completion of enrolment,
The global phase II/III study is enrolling across 15 study sites and is on track to enrol up to 270 patients by the end of the year.
Redhill is in discussions with US government agencies around potential funding to support advancement if opaganib toward potential emergency use applications and manufacturing scale-up.