On Jul. 16, 2020, RedHill Biopharma announced approval from the Ministry of Health of the Russian Federation for its Clinical Trial Authorization application for a Phase 2/3 study evaluating opaganib (Yeliva, ABC294640)1 in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia. The study was also approved in the UK and a similar application is under review in Italy with plans to further expand the study to additional countries.

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. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy. The primary endpoint of the study is to evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14. An unblinded futility only interim analysis will be conducted by an independent data safety monitoring board (DSMB) when approximately 100 subjects have been evaluated for the primary endpoint. 

The Company further announced that it 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. 

Enrollment is also ongoing for a randomized, double-blind, placebo-controlled Phase 2a clinical study with opaganib in the U.S. (NCT04414618). This study is set to enroll up to 40 patients with severe COVID-19 pneumonia requiring hospitalization and supplemental oxygen. This clinical trial is not powered for statistical significance. 

RedHill recently announced that results from the treatment with opaganib of the first patients with severe COVID-19 have been published. Analysis of treatment outcomes in five patients with severe COVID-19 showed substantial benefit to patients treated with opaganib under compassionate use in both clinical outcomes and inflammatory markers as compared to a retrospective matched case-control group from the same hospital. All patients in the opaganib-treated group were discharged from hospital without requiring mechanical ventilation, whereas 33% of the matched case-control group required mechanical ventilation. Median time to weaning from high-flow nasal cannula was reduced to 10 days in the opaganib-treated group, as compared to 15 days in the matched case-control group.