RedHill explores opaganib for ebola outbreak response

RedHill Biopharma Ltd. (NASDAQ: RDHL) announced it is discussing potential collaborations to advance its investigational drug opaganib for Ebola virus disease treatment, including with the World Health Organization's SOLIDARITY CORE clinical trial platform.

The discussions come amid an ongoing Ebola outbreak involving the rare Bundibugyo ebolavirus sub-type, for which no approved medications or vaccines exist. The WHO has indicated the current outbreak is outpacing response efforts.

Opaganib demonstrated a 70.2% mortality reduction when added to standard care in a Phase 3 COVID-19 trial, according to data published in Microorganisms. The treatment group showed 6.98% mortality compared to 23.4% in the placebo group when combined with remdesivir and corticosteroids.

Preclinical studies funded by the United States Army Medical Research Institute of Infectious Diseases showed opaganib inhibited Ebola virus in human macrophages and increased survival in one of two animal models tested. The studies also demonstrated synergistic effects when combined with Gilead Sciences' remdesivir.

The oral drug targets sphingosine kinase-2 and is designed as a host-directed therapy that could potentially be combined with direct-acting antivirals. RedHill states the drug can be stored and distributed without complex cold storage requirements.

Currently, only two treatments are FDA-approved for Ebola virus disease: Regeneron's Inmazeb and Ridgeback Biotherapeutics' Ebanga, both intravenously administered monoclonal antibodies.

RedHill has provided supply readiness and clinical data to relevant organizations to support potential clinical discussions. The company noted that inclusion in WHO platforms cannot be guaranteed and that opaganib remains an investigational drug not approved by any regulatory authority.

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