RedHill Biopharma (NASDAQ: RDHL) has 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), with top-line results expected in the coming weeks.
RedHill is a leader in the development of novel oral therapies for COVID-19, with two first-in-class oral candidates in Phase 2/3 testing. Opaganib, their lead COIVD-19 compound, 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, the company believes opaganib is likely to also maintain its activity against emerging variants, including Delta and Delta Plus. Positive US Phase 2 efficacy data has also previously been announced, it added.
READ: RedHill Biopharma reports preliminary results from new preclinical study showing potent inhibition of COVID-19 variants by opaganib
"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," said Dr Mark L. Levitt, Medical Director at RedHill.
"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," Levitt added.
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.
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 said it maintains ongoing discussions with the US Food & Drug Administration (FDA), European Medicines Agency (EMA) and other regulators, on potential pathways to approval, with the 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, RedHill added.
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