BioCryst receives $12 million to develop Ebola drug

On March 31, the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded approximately $12 million to BioCryst Pharmaceuticals of Durham, N.C., for the advanced development of a promising experimental drug for Ebola.

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, according to HHS.

“Developing drugs and vaccines to protect against Ebola has been a long-term goal of the U.S. government,” said Robin Robinson, PhD, director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA). “We are making progress quickly to develop product candidates for clinical evaluation and to make products available that protect against this virus.”

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 increasing the scalability of manufacturing, so that thousands of doses can be made with consistent product quality.

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The contract can be extended through August 2017 and up to a total of approximately $35 million. If the contract is extended, the company would conduct additional manufacturing work and other studies required to apply for FDA approval.

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BCX4430 represents the first small-molecule drug to treat Ebola that BARDA has supported. BARDA’s Ebola portfolio also includes development of the experimental monoclonal antibody cocktail ZMapp by Mapp Biopharmaceuticals and experimental vaccines from GlaxoSmithKline, BioProtection Services/NewLink Genetics, and Profectus BioSciences.

If any of these drugs or vaccines proves to be safe and efficacious BARDA could consider purchasing them under Project BioShield for the U.S. Strategic National Stockpile.

BARDA continues to seek additional proposals for the advanced development of vaccines and therapeutics against the Ebola and Marburg viruses. Program requirements are described in BARDA’s Broad Agency Announcement BARDA-BAA-13-100-SOL-00013 at https://www.fbo.gov.

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