RedHill Biopharma (Nasdaq: RDHL) today announced results from two recently completed prespecified analyses from the oral opaganib (ABC294640) Phase 2/3 study in hospitalized severe COVID-19. The first analysis showed that opaganib significantly reduced mortality when given to patients who received remdesivir and corticosteroids, the best available standard-of-care (SoC) for hospitalized patients. A second analysis further showed that opaganib delivered a significant benefit in time to recovery, defined as achieving a score of 1 or less on the WHO Ordinal Scale by Day 14. The Company is advancing regulatory discussions in multiple countries, with potential emergency and marketing authorization applications being planned for certain countries in the first half of 2022.
Prespecified analysis of Phase 2/3 opaganib data in severe COVID-19 patients showed a significant, 70.2% mortality benefit with opaganib by Day 42 when given on top of the best available standard-of-care (SoC), remdesivir and corticosteroids (6.98% mortality in the opaganib arm versus 23.4% for placebo, p-value=0.034)
A second prespecified analysis showed that opaganib also delivered a significant 34% benefit in ‘time to recovery by Day 14’, with 37.4% of opaganib-treated patients reaching this event versus 27.9% of patients treated with placebo + SoC (p-value=0.013)
These additional prespecified mortality and recovery analyses, along with previously announced data showing opaganib’s improved median time to SARS-CoV-2 viral RNA clearance, further strengthen the positive outcomes in the Phase 2/3 study post-hoc analysis. All data is being shared with regulators
Opaganib data submissions initiated in Q4/21, initial guidance on potential path to approval received from the EU’s EMA, the U.S. FDA, UK’s MHRA and others, discussions ongoing
Based on regulatory feedback and external advice received from other territories, potential emergency and marketing authorization applications planned in H1/2022
“These prespecified analyses, along with the recent data showing opaganib’s improved median time to viral RNA clearance, provide strong support for the promising results observed in the Phase 2/3 study post-hoc analysis. Oral opaganib has now shown an ability to reduce deaths, speed up recovery and clear viral RNA, all with a safety and tolerability profile similar to placebo. Strikingly, opaganib has delivered these benefits over and above the very best level of current standard-of-care, with patients receiving both remdesivir and corticosteroids,” said Dr. Mark Levitt, RedHill’s Chief Scientific Officer. “The hospitalized moderate to severe COVID-19 patient group is estimated to represent more than 50% of all hospitalized COVID-19 cases and growing. The prevalence of Omicron, new emerging variants, loss of efficacy of existing drugs against such variants and the difficulty in stopping COVID-19 early enough in its course, despite the availability of new drugs, all point very clearly to the urgent need for new, preferably orally-administered, therapeutic options, unaffected by spike protein mutations, for this underserved and substantial patient population.” |
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