Unique Mode of Action
Opaganib works by targeting the human host cell rather than the virus itself and is therefore not expected to be impacted by spike protein mutations, providing a strong rationale for its potential to address the Omicron SARS-CoV-2 variant, as well as other variants of concern
Regulatory update
Opaganib global Phase 2/3 data packages submitted to European EMA, with initial feedback expected by end of year, to the U.S. FDA with initial feedback expected in January, and to the UK MHRA, with other countries lined up
A number of pending grant applications in the U.S. and abroad with both government bodies and non-government entities
Opaganib designed for underserved hospitalized patient population with advanced disease; Opaganib treatment initiated a median of 11 days from symptom onset in the Phase 2/3 global study, compared to the limited 3-5-day from symptom onset scope of the Pfizer & Merck pills
RHB-107, RedHill's other oral COVID-19 drug candidate, expected to deliver top-line data in Q1/2022 from Part A of its Phase 2/3 study in non-hospitalized patients in the U.S. and South Africa; RHB-107 also not expected to be impacted by spike protein mutations
TEL AVIV, Israel and RALEIGH, N.C., Dec. 6, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that because opaganib's[1] proposed mechanism of action is not impacted by spike protein mutations, opaganib is expected to be unaffected by mutations associated with Omicron and other known variants of concern. The Company also provided an update on the status of its regulatory submissions for opaganib.
Increased hospitalizations in South Africa due to Omicron highlight the urgent need for drugs aimed at moderately severe COVID-19 patients with pneumonia requiring hospital treatment. By focusing on this large group of patients, opaganib, if approved, would target an entirely different and sicker patient population than the Pfizer and Merck oral drug candidates, which showed benefit only in non-hospitalized patients at the earliest stages of symptomatic infection.
Opaganib acts independently of mutations to the viral spike protein. We believe that its unique proposed mechanism of action - targeting a protein in the human cell required by the virus for replication rather than the virus itself - holds significant potential versus Omicron and other existing and emerging variants with mutations to the spike protein. Extensive clinical and non-clinical data support the rationale for accelerating this program, including clinical data from Phase 2 and Phase 2/3 studies, compassionate use experience and strong inhibition against variants of concern, including Delta.
"Omicron is just another reminder that COVID-19 is an endemic virus at this point, and it is not going away. The evolution of this virus will continue as long as it circulates, and we will need to continue to tweak our vaccines and monoclonal antibodies in order to respond to new variants as they arise. Most importantly, this underscores the need for safe and effective anti-viral therapies that will continue to work no matter which variants present themselves. It is vital that focus, time and resources are given to the development of anti-viral therapies that can effectively treat those COVID-19 high risk patients, preferably without concern for variants and mutations," said Kevin Winthrop, MD, MPH, Professor of Infectious Diseases at Oregon Health & Science University. "The post-hoc data from the opaganib Phase 2/3 study in moderate and severe COVID-19 patients is intriguing and suggests the possibility that opaganib might prove itself as an effective anti-viral in this setting. In a subpopulation of patients defined as moderately severe based on their level of baseline oxygen supplementation, mortality was 62% lower in those using opaganib (16% placebo Vs. 6% opaganib). The results suggest a sub-group of patients who would likely benefit from this therapy, and they highlight the need for additional studies in the development of this therapy."
Regulatory & Development Update:
Given the promising clinical results to-date in the moderately severe h...
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