RedHill Biopharma expands manufacturing capacity of Covid-19 drug candidate opaganib in US

RedHill Biopharma has forged partnerships with a couple of US-based manufacturers for large-scale manufacturing of opaganib, its Covid-19 drug candidate.

The Israeli biopharma company said that the collaborations further progress its ongoing preparations to underpin potential emergency use applications for opaganib for the treatment of severe Covid-19 pneumonia, which are anticipated as early as Q1 2021.

RedHill Biopharma had recently announced collaborations with European and Canadian manufacturers.

Reza Fathi – RedHill Biopharma R&D Senior VP said: “We are expanding our U.S.-based manufacturing capacity for orally administered opaganib, ahead of potential emergency use applications as early as Q1/2021.

“Together with our recently announced similar partnerships in Europe and Canada and in light of our rapidly progressing Phase 2/3 opaganib COVID-19 program, these new U.S. partnerships better place RedHill to meet potential demand for opaganib, if approved.”

According to RedHill Biopharma, opaganib is an orally administered, sphingosine kinase-2 (SK2) selective inhibitor that has dual anti-inflammatory and antiviral activity that acts on the cause and effect of Covid-19. It is said to target a host cell component involved in viral replication, thereby potentially minimizing the possibility of resistance due to viral mutations.

The Israeli biopharma company said that enrollment in a 270-patient global phase 2/3 trial with opaganib in severe Covid-19 pneumonia patients is more than 50% complete.

Parallelly, a phase 2 study with opaganib in the US has enrolled all 40 subjects.