Novel, Dual Antiviral, Anti-inflammatory Investigational COVID-19 Pill Demonstrated Ootent Inhibition
Israel-based RedHill Biopharma Ltd. announced that all treatment and follow-up has now been completed in the 475-patient global Phase 2/3 study with opaganib in patients hospitalized with severe COVID-19 pneumonia.
Top-line results are expected in the coming weeks, stated the company's press release.
Opaganib (Yeliva®, ABC294640), 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, that is host-targeted and is therefore expected to be effective against emerging viral variants. In addition, Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib recently demonstrated potent in vitro inhibition of the Beta (South African) and Gamma (Brazilian) SARS-CoV-2 coronavirus variants, and based on its unique host-targeted mechanism and the preliminary results from this study, the company believes opaganib is likely to also maintain its activity against emerging variants, including Delta and Delta Plus.
"Emerging data is showing that variants are capable of evading vaccines' effects. Not only does this threaten efforts to control the pandemic, but it also brings into sharp focus the urgent need for effective oral COVID-19 therapies capable of working despite the emergence of variants. This makes the completion of this study even more significant, given its potential to be a game-changer in the treatment of COVID-19," commented Mark L. Levitt, M.D., Ph.D., Medical Director at RedHill.
The primary endpoint of the global Phase 2/3 study, authorized in ten countries, is the proportion of patients breathing room air without oxygen support by Day 14. The study has also captured additional important outcome measures, such as the time to hospital discharge, the improvement according to the World Health Organization Ordinal Scale for Clinical Improvement, and incidence of intubation and mortality.
Located in Tel Aviv, Israel, Redhill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.