RedHill Biopharma Ltd., a specialty biopharmaceutical company, was selected by the U.S. government’s Biomedical Advanced Research and Development Authority (BARDA), a center of the Department of Health and Human Services (HHS)’ Administration for Strategic Preparedness and Response (ASPR), to advance opaganib2 to treat exposure to Ebola virus disease (EBOV).
 
Under this cost-sharing contract, BARDA will provide partial funding for the company to further advance opaganib to help mitigate infection and contain EBOV outbreaks. To date, opaganib has made positive development progress on the expected Animal Rule pathway towards potential approval as a treatment for EBOV. The Animal Rule allows for the use of pivotal animal model efficacy studies to support U.S. FDA approval of new drugs when human clinical trials are not ethical or feasible.
 
Opaganib has shown a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo EBOV study, making it the first host-directed molecule to show activity in EBOV. Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro EBOV study.

“EBOV is deadly, killing, on average, half of all those who contract it. Currently only Inmazeb, a combination of three monoclonal antibodies, and Ebanga, a single monoclonal antibody, are FDA-approved to treat EBOV, as such there is an urgent medical need for additional therapies. There are also enormous geopolitical and logistical challenges to overcome in managing outbreaks such as EBOV, and so new host-directed, small molecule therapeutic options for biodefense and global health preparedness could prove to be major life-saving advances – this is especially true if they are capable of viral mutation-resistance, have extended shelf-lives for long-term storage, are relatively straightforward to transport to hard-to-reach territories, and are easy to administer without the need for cold-storage or injections.”
 
Opaganib is currently also in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, acute respiratory distress syndrome (ARDS) and radiological and chemical protection or mitigation.
 
This project is supported in part with federal funds from BARDA under contract number 75A50124C00059.