RedHill Biopharma Ltd. ("RedHill" or the "Company"), a specialty pharma company that is a leader in the development of novel oral therapies for COVID-19, today announced that all treatment and follow-up has now been completed in the 475-patient global Phase 2/3 study with opaganib (ABC294640) in patients hospitalized with severe COVID-19 pneumonia (NCT04467840). Top-line results are expected in the coming weeks.
Opaganib is a novel, host-targeted, dual antiviral and anti-inflammatory investigational pill in advanced clinical development for the treatment of severe COVID-19. Opaganib recently demonstrated potent in vitro inhibition of the Beta (South African) and Gamma (Brazilian) variants and based on its unique host-targeted mechanism and the preliminary results from this study, we believe opaganib is likely to also maintain its activity against emerging variants, including Delta and Delta Plus. Positive U.S. Phase 2 efficacy data has also previously been announced.
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. We can now concentrate on getting all the data collected, cleaned and collated in the database ready for analysis and subsequent reporting. This means we are weeks away from knowing if we are a big step closer to having a paradigm-shifting oral therapy for hospitalized COVID-19 patients."
Mark L. Levitt, MD, Ph.D., Medical Director, RedHill Biopharma
The primary endpoint of the global Phase 2/3 study, approved in 10 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, improvement according to the World Health Organization Ordinal Scale for Clinical Improvement and incidence of intubation and mortality.
Evaluations of blinded blended intubation and mortality rates from the Phase 2/3 study have been encouraging compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations . Furthermore, four independent DSMB recommendations to continue the study have been received following three unblinded safety reviews and an unblinded futility analysis. Additionally, encouraging use of opaganib under compassionate use exemption has been experienced in Israel and Switzerland.
The Company maintains ongoing discussions with the FDA, EMA and other regulators, on potential pathways to approval, with next steps to be guided by study results. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various countries.