The Department of Health and Human Services (HHS) and its Office of the Assistant Secretary for Preparedness and Response (ASPR) have awarded approximately $12 million to BioCryst Pharmaceuticals of Durham, N.C., for the advanced development of a promising experimental drug for Ebola, including preparing for large-scale manufacturing of the drug and conducting related studies.
The initial work will be undertaken over the next 18 months with support from ASPR’s Biomedical Advanced Research and Development Authority (BARDA). The contract can be extended through August 2017 for up to a total of approximately $35 million.
BioCryst’s drug, BCX4430, is a small molecule that prevents the Ebola virus from reproducing in the body. In non-human primate studies, the drug was effective against Ebola virus and Marburg virus, another virus in the filovirus family, indicating that BCX4430 may be useful as a broad spectrum antiviral drug.
Under product development funding from the National Institutes of Health, BioCryst currently is conducting Phase 1 safety studies of BCX4430 for safety in healthy volunteers. If these studies show that the drug is safe, BCX4430 could become one of the possible treatments tested for efficacy in clinical studies.
While these studies are underway, BARDA will support the company’s ongoing efforts to improve manufacturing processes and scale up production in facilities in the United States. This work includes improving manufacturing processes to increase product yield, reduce process steps, and increase the scalability of manufacturing, so that thousands of doses can be made with consistent product quality.