Covid Pill Opaganib May Be Effective Against Omicron, Other Variants Of Concern: RedHill

Israel-based RedHill Biopharma says its oral Covid-19 drug candidates might not be affected by mutations associated with Omicron.

Redhill says its Covid pills might not be affected by mutations associated with Omicron .

The rising Omicron threat has prompted scientists around the world to accelerate research on potential drugs against Covid-19 disease. Israel-based RedHill Biopharma is also aggressively working on developing two promising Covid-19 pills, which are expected to be affective against Omicron and other known Coronavirus' variants of concern.

The company on Tuesday announced that its Covid pill Opaganib is expected to be unaffected by mutations associated with Omicron and other known variants of concern as its proposed mechanism of action is not impacted by spike protein mutations. Studies have shown the efficacy of the pill in reducing mortality and getting patients out of hospital faster.

"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," the company said in a statement released on it website.

Opaganib may benefit those hospitalised with COVID-19

In view of the increased hospitalizations in South Africa due to Omicron , RedHill in its statement highlighted the urgent need for drugs aimed at moderately severe COVID-19 patients with pneumonia requiring hospital treatment.

Oral Covid-19 drug candidates are also being developed by Pfizer and Merck, but they showed benefit only in non-hospitalised patients at the earliest stages of symptomatic infection. Opaganib would target those who are hospitalised with Covid-19 and are more severe.

"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," the company stated.

Results of the Opaganib Phase 2/3 study involving moderate and severe Covid-19 patients showed the potential of Opaganib as an effective anti-viral drug. In moderately severe patients, Opaganib use helped reduced mortality by 62 per cent.

The company has already submitted Opaganib global Phase 2/3 data packages to the U.S. FDA, the European Medicines Agency (EMA) and the UK (MHRA) seeking scientific advice on the potential path towards approval of opaganib. The initial feedback from EMA is expected by end of year, and from the FDA in January 2022.

Pills for non-hospitalised Covid-19 patients under evaluation

The company's another oral Covid-19 drug candidate, called RHB-107, is currently being evaluated in a Phase 2/3 study in non-hospitalised Covid-19 patients in the US and in South Africa. The results of the study are expected to be out in the first quarter of 2022. However, the company said that the second oral drug is also not expected to be impacted by spike protein mutations.

According to Gilead Raday, RedHill's Head of R&D, both these drugs have unique human cell-targeted mechanisms of action that act independently of mutations at the spike protein.