RedHill Biopharma Ltd (RDHL)

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RedHill Biopharma says its experimental oral COVID-19 drugs not affected by Omicron

Dec. 06, 2021 9:00 AM ETRedHill Biopharma Ltd. (RDHL)

By: Dulan Lokuwithana, SA News Editor2 Comments

RedHill Biopharma (NASDAQ:RDHL) announced that the newly detected Omicron variant of the coronavirus is unlikely to impact its experimental COVID-19 therapies, Opaganib and RHB-107.

Opaganib developed for hospitalized patients with the advanced form of the disease, targets the human host cell rather than the virus, and, therefore, it is “not expected to be impacted by spike protein mutations,” the company said.

While COVID-19 pills developed by Pfizer (NYSE:PFE) and Merck (NYSE:MRK) require a 3-5-day period to begin their treatments following the onset of symptoms, Opaganib is started at a median of 11 days following the beginning of symptoms.

In a regulatory update, RedHill (RDHL) said that Phase 2/3 data for Opaganib have been submitted to the European Medicines Agency (EMA) and the FDA with initial feedback from two regulatory agencies expected by the end of the year and January 2022, respectively.

The data submissions have already been made to the UK (MHRA), and the regulatory submissions to several other countries, including South Africa, Russia, and Israel, are also lined up.

Topline data from Part A of its Phase 2/3 study for RHB-107 in non-hospitalized patients is expected in Q1 2022.

Read more on upcoming milestones for RedHill (RDHL) as announced by its management last month.