National Treasure Investment Firm Redhill Bio: "Oral COVID-19 Treatment Effective Against Omicron as Well"

[Asia Economy Reporter Jang Hyowon] Kookbo Co., Ltd., a KOSPI-listed company, announced that the oral COVID-19 treatment developed by the US/Israel biotechnology company ‘RedHill Biopharma,’ in which it has acquired shares, is expected to address the Omicron variant concerns.

According to Kookbo, on the 6th, RedHill stated through local media that the oral COVID-19 treatment currently under development, Opaganib, is expected not to be affected by mutations in the spike protein because it targets human host cells rather than the virus itself.

Additionally, global Phase 2/3 clinical trial data have been submitted to the European EMA, with review results expected by the end of December. The US FDA’s decision is anticipated in January next year, and results from other regulatory agencies, including the UK MHRA, are also awaited.

Through local articles, RedHill emphasized that while Pfizer and Merck’s oral treatments have reported study results limited to within 3 to 5 days after symptom onset, Opaganib’s global Phase 2/3 study demonstrated efficacy by starting treatment at an average of 11 days after symptom onset.

Opaganib is a sphingosine kinase-2 (SK2) inhibitor that targets the SK2 human host cell factor rather than the virus itself, operating independently of spike protein mutations found in Omicron and other variants.

COVID-19 uses host factors at various stages of viral infection such as cell entry and replication, and SK2 is one of these factors, potentially serving as a broad antiviral target. Therefore, inhibition of SK2 can simultaneously deliver two antiviral and anti-inflammatory effects in COVID-19 cases. Moreover, because Opaganib targets SK2 rather than the virus itself, RedHill expects it to maintain efficacy regardless of the emergence of new variants like Omicron.

Furthermore, RedHill highlighted the urgent need for oral treatments for moderate to severe COVID-19 pneumonia patients amid the surge of cases caused by the Omicron variant originating in South Africa. They stated that if Opaganib receives emergency approval, unlike Pfizer and Merck’s oral treatments which benefited only non-hospitalized patients in the early stages of symptomatic infection, it will benefit patients with more severe symptoms.