RedHill Biopharma (Nasdaq: RDHL) today reported new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia showing that treatment with oral opaganib (ABC294640) vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in a group of 251 hospitalized, moderately severe COVID-19 patients, comprising 53% of the 475 study participants.
· 62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients group treated with opaganib vs. the placebo-controlled arm (7 deaths in the 117-patient opaganib arm vs. 21 deaths in the 134-patient placebo arm; nominal p-value=0.019)
· 21% statistically significant efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (77% of opaganib patients vs 63.5% on placebo; nominal p-value=0.033)
· A median four days earlier hospital discharge for opaganib-treated patients vs. placebo (10 days for opaganib arm vs. 14 days for placebo) a cumulative saving of 524 days of hospitalization across the group by Day 42 (nominal p-value=0.0195)
· The moderately severe group comprised 53% of study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (inhaled supplemental oxygen via nasal cannula or face mask)
· Data indicates a potential meaningful benefit with opaganib for these hospitalized, moderately severe COVID-19 patients - a group at high risk of disease progression, morbidity and mortality; the data also supports opaganib’s potential use in earlier stages of COVID-19 disease, consistent with opaganib’s U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants
· RedHill will hold a conference call on Thursday, October 7, 2021, at 08:30 am EDT to further discuss these additional analyses
“These new findings support the potential for opaganib’s use in hospitalized, moderately severe COVID-19 patients - a key group of patients that are at high risk of disease progression, morbidity and mortality, and who may benefit from opaganib’s combined antiviral and anti-inflammatory activities,” said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. “The results provide a strong rationale for opaganib’s potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalized COVID-19 patients. The Phase 2/3 study results are also consistent with opaganib’s earlier U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human bronchial epithelial cells, providing further support for its potential in earlier stages of disease where viral load is higher.”
“We are excited about this promising and robust dataset. We are not aware of any other novel oral pill-based therapy that has shown a similar magnitude of difference in the mortality outcomes of hospitalized patients who are at this moderately severe stage of disease. The data indicates opaganib’s potential to provide an effective option, in an easy to take and distribute pill-form, to help prevent patient deterioration and mortality,” said Dror Ben-Asher, RedHill’s CEO. “Pinpointing the most relevant target patient population is particularly challenging with novel drugs, novel mechanisms of action and a previously unknown disease. This trial and these data have given us a clear indication of which groups of patients are likely to benefit the most from opaganib.”
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