RedHill Biopharma to start late-stage study in UK for opaganib for Covid-19

RedHill Biopharma (RDHL -6.5%) announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved the Company’s clinical trial application to commence a Phase 2/3 study evaluating opaganib in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia.

The multi-center, randomized, double-blind, parallel-arm, placebo-controlled Phase 2/3 study will enroll up to 270 patients, with primary endpoint of 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 commenced enrollment for a randomized, double-blind, placebo-controlled Phase 2a study with opaganib in the US; the study will enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen.

https://seekingalpha.com/news/3587044-redhill-biopharma-to-start-late-stage-study-in-uk-for-opaganib-for-covidminus-19