RedHill: Clinical Trial Application Approved In Russia For Phase 2/3 Study With Opaganib

(RTTNews) - RedHill Biopharma Ltd. (RDHL) received approval in Russia for a phase 2/3 study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection and pneumonia. The multi-center, randomized, double-blind, parallel-arm, placebo-controlled phase 2/3 study is set to enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen.

The study was also recently approved in the UK and a similar application is under review in Italy. The company also has received approval from the Israeli Ministry of Health to initiate a study evaluating opaganib in up to 50 patients with severe COVID-19 infection and pneumonia.