Biopharmaceutical company RedHill Biopharma Ltd. (RDHL) reported Monday new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia. The treatment with oral opaganib (ABC294640) vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in a group of 251 hospitalized, moderately severe COVID-19 patients, comprising 53% of the 475 study participants.
These important new results are from a post-hoc analysis of data from the 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline. Patients with FiO2 = 60% are still considered to be severely affected and typically require oxygen supplementation via a nasal cannula or face mask.
The multi-center, randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study enrolled 475 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects were randomized at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy.
The new data of the sub-group analysis follows the Company's previously announced top-line results of the Phase 2/3 study.
Opaganib is a novel small molecule investigational drug in oral pill form. Opaganib has a unique dual antiviral and anti-inflammatory mechanism of action that acts on the viral cause and inflammatory effect of COVID-19.
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