Benzinga | Dec 6, 2021 11:58AM EST

RedHill Biopharma Says Opaganib Mechanism Against COVID-19 Not Impacted By Omicron Mutations

RedHill Biopharma Ltd (NASDAQ:RDHL) announced that opaganib's 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.

* Opaganib acts independently of mutations to the viral spike protein said the company.

* The company believes that its 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.

* 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).

* RDHL submitted data packages to the FDA, the European Medicines Agency, and the UK (MHRA), actively seeking scientific advice on the potential path towards approval of opaganib.

* The EMA has indicated a rapid procedure timeline and expects their advice by the end of the year, with preliminary feedback from the FDA expected in January 2022.

* Price Action: RDHL shares traded 0.39% higher at $2.56 during the market session on the last check Monday.