Published On: Thu, Nov 26th, 2020

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

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

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