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RedHill Biopharma on go with Phase 2/3 Covid-19 study with opaganib in Brazil

September 22, 2020

The Brazilian Health Regulatory Agency has signed off the ongoing global Phase 2/3 study of RedHill Biopharma’ (RDHL +1.5%) opaganib, sphingosine kinase-2 selective inhibitor, in patients hospitalized with severe COVID-19 pneumonia.

The study has been in Brazil, Israel, U.K., Italy, Russia and Mexico, and is expected to enroll up to 270 patients requiring hospitalization and treatment with supplemental oxygen.

In parallel, U.S. Phase 2 study with opaganib in patients with severe COVID-19 pneumonia is ~75% enrolled, with enrollment set to be completed in the coming weeks. Recently, a pre-scheduled independent Safety Monitoring Committee recommended that the study continue without change.

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