RedHill Biopharma (NASDAQ:RDHL) Ltd. has reported important new data showing treatment with oral opaganib (ABC294640) versus 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 coronavirus (COVID-19) patients.
The data comes from a post-hoc analysis of data from a group of 251 patients, 53% of the 475-patient study cohort, from the global Phase 2/3 study of opaganib in hospitalized patients with severe coronavirus (COVID-19) pneumonia who required a Fraction of inspired Oxygen (FiO2) up to 60% at baseline. Patients with FiO2 less than or equal to 60% are still considered to be severely affected and typically require oxygen supplementation via a nasal cannula or face mask.
The analysis further demonstrated a 21% statistically significant efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint and a median of 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 (Given the post-hoc characteristics of this subset, statistical inferences of significance cannot be formally attributed).
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"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," Dr Mark L. Levitt, medical director at RedHill said in a statement.
"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," Dr Levitt added.
Promising and robust dataset
Dror Ben-Asher, RedHill's CEO commented: "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." "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," the RedHill Biopharma (NASDAQ:RDHL) CEO added.
"Analyses of the FiO2 up to 60% patients, who were treated with either opaganib or placebo in addition to standard-of-care (including dexamethasone and/or remdesivir) demonstrate consistent benefit across endpoints, in this group of hospitalized moderately severe patients. RedHill intends to discuss the study outcomes with regulators, including US Food & Drug Administration (FDA) and US government agencies, as well as other regulators and governments and international agencies, to help determine next steps. Opaganib is a novel small molecule investigational drug in oral pill form.
Opaganib has a unique dual antiviral and anti-inflammatory mechanism of action that acts on the viral cause and inflammatory effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication and is expected to be effective against emerging viral variants, having already preclinically demonstrated strong inhibition against variants of concern, including Delta.
Webcast on October 7, 2021
The company also announced that it will host a webcast on Thursday, October 7, 2021, at 8.30am. EDT, during which it will present the additional analysis of the Phase 2/3 study results and answer questions. The webcast including slides will be broadcast live on the company's website - https://www.redhillbio.com/investors/events-and-presentations/default.aspx
Contact the author at jon.hopkins@proactiveinvestors.com
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