RedHill Biopharma, a specialty biopharmaceutical company, has announced collaborations with two specialist pharmaceutical manufacturers in Europe and Canada to ramp-up manufacturing of opaganib, currently in swiftly progressing global Phase II/III and US Phase II studies for severe COVID-19 pneumonia, to support potential emergency use applications and subsequent demand.
Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, potentially minimizing the likelihood of viral resistance.
The late-stage development program for opaganib in patients with severe COVID-19 pneumonia includes the US Phase II study – ongoing in eight clinical trial sites – and is approaching completion of enrollment, and recently passed a second independent committee review, with data expected to follow before the end of this year; and the global Phase II/III study, which is enrolling rapidly across 15 study sites and is on track to enroll up to 270 patients by the end of the year.
Both studies are randomized, double-blind, parallel-arm, placebo-controlled trials with opaganib in patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue.
The company is in discussions with US government agencies around potential funding to support the rapid advancement of opaganib toward potential emergency use applications and manufacturing scale-up.
“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, RedHill’s Senior VP, R&D.