National Treasure "Redhill 'Opaganib' Confirmed to Strongly Suppress Omicron"

[Asia Economy Reporter Jang Hyowon] RedHill Biopharma, a US-Israeli biotechnology company in which Kookbo, a KOSPI-listed company, has acquired shares, announced on the 12th that in an in vitro efficacy test, the oral treatment for moderate to severe COVID-19, Opaganib, was observed to have strong inhibitory effects against the Omicron variant while maintaining host cell viability.

According to the company, the test report conducted by the WHO Collaborating Center at the School of Public Health, The University of Hong Kong, explained that Opaganib’s unique mechanism targeting human cells and its antiviral and anti-inflammatory actions are expected to be effective against Omicron, the new Omicron variants BA.2, XE, and future variants regardless of mutations in the viral spike protein.

Previously reported Phase 2/3 clinical data showed that in key subgroups of hospitalized patients with moderate to severe COVID-19 treated with Opaganib, there was a reduction in mortality, improved viral RNA clearance, and shortened recovery time. Specifically, Opaganib underwent a global Phase 2/3 study targeting patients hospitalized with severe COVID-19 pneumonia (NCT04467840).

In a pre-specified analysis of all Phase 2/3 study patients who tested PCR positive at screening, Opaganib improved the median time to viral RNA clearance by at least 4 days, achieving viral RNA clearance within a median of 10 days, whereas the control group’s median time did not reach clearance by the end of the 14-day treatment period in the placebo group.

Additional pre-specified analyses of key subpopulations in the Phase 2/3 study showed a 70% reduction in mortality and approximately a 34% benefit in recovery time for patients treated with Opaganib.

The Opaganib test against the Omicron variant was conducted by Dr. Michael Chan, senior researcher at the Center for Immunology and Infection (C2i), School of Public Health, The University of Hong Kong, a globally renowned infectious disease research center.

He evaluated, "In the study, we were able to observe the potent inhibitory effect of Opaganib on viral replication in the model closest to representing the clinical pathophysiology of Omicron. This is a promising result demonstrating the Opaganib hypothesis of host antiviral activation and its effectiveness regardless of viral variants."

Currently, RedHill is known to be submitting data requirements and engaging in discussions related to Opaganib approval in the US, Europe, the UK, and multiple other countries.

Last November, Kookbo acquired shares in RedHill Biopharma, securing the first negotiation rights for distribution contracts responsible for domestic distribution of Opaganib as well as distribution in major Asian regions. Additionally, a formal license agreement was signed granting exclusive rights for the domestic commercialization of Opaganib.