RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma to launch late-stage study of opaganib in COVID-19

Jun. 29, 2020 2:14 PM ET|About: RedHill Biopharma Ltd. (RDHL)|By: Vandana Singh, SA News Editor

RedHill Biopharma (RDHL -6.5%) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has signed off on a Phase 2/3 clinical trial evaluating opaganib in hospitalized patients with severe COVID-19 pneumonia.

The multi-center, randomized, double-blind, parallel-arm, placebo-controlled study will enroll up to 270 patients. The primary endpoint will be the proportion of patients requiring intubation and mechanical ventilation by Day 14.

Futility only interim analysis will be conducted by an independent data safety monitoring board when ~100 subjects have been evaluated for the primary endpoint.

In parallel, RedHill has commenced enrollment in a U.S.-based randomized, double-blind, placebo-controlled Phase 2a trial testing opaganib in up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen.

Opaginib, branded as Yeliva, inhibits an enzyme called sphingosine kinase-2 (SK2) which blocks the synthesis of a lipid-signaling molecule called sphingosine 1-phosphate (S1P) that promotes cancer cell growth and pathological inflammation.