Brazil Approves Phase 2/3 COVID-19 Study with Orally-Administered Opaganib

The Brazilian Health Regulatory Agency has approved RedHill Biopharma's ongoing global Phase 2/3 study evaluating orally-administered opaganib in patients hospitalized with severe COVID-19 pneumonia. Announced on September 22, 2020, 

Opaganib is a first-in-class, orally-administered, sphingosine kinase-2 selective inhibitor with demonstrated dual anti-inflammatory and antiviral activity that targets a host cell component, unaffected by viral mutation, thus minimizing the likelihood of resistance.

Opaganib completely inhibited SARS-CoV-2 viral replication in an in vitro human lung cell model, comparing favorably with remdesivir, the positive control in the study.