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Opaganib reduces COVID-19 mortality by 62 percent in Phase II/III study

  • 8 ottobre 2021
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RedHill BioPharma has reported new data from the opaganib global Phase II/III study in hospitalised patients with severe COVID-19 pneumonia showing that treatment with oral opaganib (ABC294640) versus the placebo-controlled arm resulted in a 62 percent 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 hospitalised, moderately severe COVID-19 patients, comprising 53 percent of the 475 study participants.

The multi-center, randomized, double-blind, parallel-arm, placebo-controlled global Phase II/III 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 II/III study. Analysis of the top-line data is still ongoing, including further analysis of the potential for increased benefit of treatment with opaganib in patients at earlier stages of disease. 

Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta.

Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

The multi-centre, randomised, double-blind, parallel-arm, placebo-controlled global Phase II/III study enrolled 475 subjects with severe COVID-19 pneumonia requiring hospitalisation and treatment with supplemental oxygen. Subjects were randomised at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy. Key data from the Phase II/III study include:

  • Opaganib treatment resulted in a statistically significant 62 percent reduction in mortality

  • Seventy-seven percent of opaganib-treated patients reached room air by Day 14 versus 63.5 percent for placebo – an efficacy benefit of 21 percent with opaganib

  • Patients treated with opaganib showed median time of 10 days to discharge versus 14 days for the placebo arm, resulting in a saving of four days hospitalisation per opaganib patient and saving a total of 524 cumulative days of hospitalisation across the group by Day 42

  • Overall adverse events were balanced between the opaganib and placebo groups, suggesting good safety, with no new safety signals emerging, further supporting potential use in this patient population and earlier stage populations.

 

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