RedHill Biopharma’s investigational Covid-19 treatment opaganib is effective against the Omicron variant, an in vitro study said. Attention is on whether the study results will benefit Kukbo, which licensed in the oral Covid-19 treatment from RedHill Biopharma.
The Israel-based biopharmaceutical company said on Monday that its oral treatment candidate opaganib (ABC294640) for treating patients hospitalized for moderate to severe Covid-19 demonstrated efficacy against Omicron in an in vitro environment.
The study was conducted by the Centre for Immunology and Infection, an infectious disease research center at the University of Hong Kong.
Dr. Michael Chan, principal investigator of the Centre for Immunology and Infection, said, “The study results showed opaganib exerting potent inhibition of Omicron SARS-CoV-2 variant viral replication in a model that we believe comes as close as currently possible to representing the Omicron clinical pathophysiological pathway.”
He added that the outcomes are highly encouraging and give more weight to opaganib’s hypothesized host-mediated antiviral activity regardless of viral variant.
Reza Fathi, Redhill’s senior vice president of R&D, said the test of opaganib on inhibition of Omicron’s viral replication using an ex vivo human respiratory explant model, based on the finding that Omicron has a replication advantage in respiratory tract explants culture.
Fathi noted that the outcomes were consistent with the results from the phase 2/3 study, where opaganib accelerated viral RNA clearance by more than four days, along with reducing mortality in key subgroups and shortening the time to recovery.
The Covid-19 pill showed effectiveness in advanced patients with a median of 11 days from the onset of symptoms. He added that it would be the first oral drug for moderate to severe Covid-19 patients.
Based on these results, Redhill is discussing confirmatory data requirements and procedures for approval with regulators in the U.S., Europe, the U.K., and other countries, the company said.
On March 15, Redhill signed an exclusive license agreement with Kukbo, a Korean company, for opaganib. Whether the latest study on Omicron will benefit Kukbo is drawing attention.
Kukbo paid a $1.5 million upfront payment and plans to provide up to $5.6 million in milestone payments.
However, the two companies have yet to discuss the procedures for opaganib approval with the Ministry of Food and Drug Safety.