RedHill's Opaganib Makes Progress in Ebola Virus Therapy

RedHill Biopharma Ltd. (Nasdaq: RDHL), a specialty biopharmaceutical company, announced that the U.S. government's Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services' (HHS) Administration for Strategic Preparedness and Response (ASPR), has chosen opaganib for development as a treatment for Ebola virus disease (EBOV).

Through a cost-sharing contract, BARDA will partially fund RedHill’s efforts to advance opaganib in combating EBOV and containing outbreaks. Opaganib has made promising progress towards potential approval via the FDA’s Animal Rule, which allows animal studies to support drug approval when human trials are not ethical or feasible.

Guy Goldberg, RedHill’s Chief Business Officer, emphasized the deadly nature of Ebola, which kills about half of those infected, and the ongoing need for additional, effective treatments. Currently, only two FDA-approved therapies—Inmazeb™ and Ebanga™—are available for EBOV, highlighting the urgent need for more accessible treatments that are resistant to viral mutations, have long shelf-lives, and can be easily transported and administered without cold storage.

Opaganib has shown a statistically significant increase in survival time in EBOV studies conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), making it the first host-directed molecule to demonstrate efficacy against the virus. Additionally, it displayed a synergistic effect when combined with remdesivir (Veklury®, Gilead Sciences Inc.) in a U.S. Army-funded study, enhancing potency while maintaining cell viability.

Opaganib is also under development for several other conditions, including cancer, viral infections, inflammation, diabetes, obesity-related diseases, COVID-19, acute respiratory distress syndrome (ARDS), and radiological and chemical protection.