RedHill Biopharma has announced that the US 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), has selected opaganib2 for development 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 mitigate infection and contain EBOV outbreaks. To date, opaganib has made positive development progress on the expected Animal Rule pathway toward potential approval as a treatment for EBOV.
The Animal Rule allows for the use of pivotal animal model efficacy studies to support the US Food and Drug Administration (FDA) approval of new drugs when human clinical trials are not ethical or feasible.
"EBOV is deadly, killing, on average, half of all those who contract it. This year marks 10 years since the West Africa Ebola epidemic in which 11,000 people died, and yet there are still no host-directed, small molecule therapies approved to provide effective and useable treatment strategies," said Guy Goldberg, RedHill's Chief Business Officer.
"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 effective and easy to distribute and administer EBOV therapies. There are also enormous geopolitical and logistical challenges to overcome in managing outbreaks such as EBOV, and others like Mpox, 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," said Goldberg.
Opaganib delivered 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 US Army-funded and conducted in vitro EBOV study.
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.
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