RedHill Biopharma Ltd. (NASDAQ:RDHL) has said it is setting the pace in the global quest for an oral COVID-19 treatment, with two oral COVID-19 drug candidates amongst the most advanced in development.
A signal of the progress RedHill is making came with the presentation, at this week’s World Microbe Forum (WMF) 2021, of positive safety and efficacy data from its Phase 2 study of oral opaganib in hospitalized patients with COVID-19 pneumonia.
"The need for an effective oral therapy to treat COVID-19 is clear. Such a therapy would greatly improve our ability to manage this pandemic," said Kevin Winthrop, Professor of Infectious Diseases at Oregon Health & Science University, who presented the findings at WMF.
READ: RedHill completes enrollment in the global Phase 2/3 severe COVID-19 study with oral opaganib
"These data, from this proof-of-concept clinical study of opaganib in patients with severe COVID-19, suggest a potential role of SK2 inhibition in combating the effects of this virus. With much more data on opaganib expected in the coming weeks, we could make some real progress toward having access to a much-needed oral therapy for patients who currently have a paucity of options available to them," Professor Winthrop added.
RedHill’s Medical Director, Dr Mark L. Levitt commented: "Presentation of these positive data from our exploratory Phase 2 study support our growing confidence that opaganib could be the first novel, oral therapy to demonstrate efficacy in the treatment of COVID-19 in a large late-stage study. With the recent completion of enrollment of our 475- patient global Phase 2/3 study, we will have a clearer picture of that in the very near future".
Data presented from the study, in which patients were randomized to receive either opaganib or placebo in addition to standard of care (SoC), predominantly including dexamethasone and/or remdesivir, included:
- 50% of patients treated with opaganib (n=22) reached room air by Day 14 compared to 22% in the placebo group (n=18). The benefit of reaching room air by Day 14 for patients on opaganib was maintained regardless of whether the patients were receiving dexamethasone and/or remdesivir
- 86.4% of patients treated with opaganib were discharged from hospital by Day 14 compared to 55.6% of patients treated with placebo
- Median time to discharge was 6 days for the opaganib group compared to 7.5 days for the placebo group
- 81.8% of opaganib patients achieved a 2-point improvement in the WHO Ordinal Scale compared to 55.6% of patients in the placebo group – achieved in a median time of 6 days versus 7.5 days, respectively
- No significant differences in safety-related measures between the two groups (with diarrhea being the main treatment-emergent difference in tolerability)
Dr Levitt highlighted opaganib’s mechanism of action as a potential benefit in achieving these results: "Opaganib acts on both the cause and effect of COVID-19 via a unique dual antiviral and anti-inflammatory mode of action. Being host-targeted, opaganib is also expected to maintain effect against the emerging SARS-CoV-2 variants, which continue to threaten the progress being made against the pandemic and underscore the urgent need for effective COVID-19 therapeutics," he added
Looking ahead towards opaganib Phase 2/3 top-line data
Enrollment was recently completed for opaganib’s global 475-patient Phase 2/3 study in severe COVID-19. The study is expected to complete in the coming weeks with a primary endpoint of proportion of patients breathing room air without oxygen support by Day 14.
Additional important outcome measures, such as time to discharge from hospital, improvement according to the World Health Organization Ordinal Scale for Clinical Improvement and incidence of intubation and mortality, will also be captured in the follow-up period of up to 6 weeks.
The study received four independent DSMB recommendations to continue following unblinded safety reviews and a futility review. Additionally, an evaluation of the blinded blended intubation and mortality rates to date was encouraging as compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations.
Contact the author at jon.hopkins@proactiveinvestors.com
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