The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) today announced the award of approximately $12 million to BioCryst Pharmaceuticals of Durham, North Carolina, for the advanced development of a promising experimental drug for Ebola.
BioCryst’s drug, BCX4430, is a small molecule RNA dependent-RNA polymerase inhibitor 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.
BCX4430 has actually shown activity against more than 20 RNA viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses.
Work under this contract will be undertaken over the next 18 months with support from ASPR’s Biomedical Advanced Research and Development Authority (BARDA) with base funding of $12.1 million to support BCX4430 drug manufacturing. $22.9 million in additional development options may be exercised by BARDA, bringing the potential value of the contract to $35.0 million.
Under product development funding from the National Institutes of Health (NIH), 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.
“Developing drugs and vaccines to protect against Ebola has been a long-term goal of the U.S. government,” explained BARDA Director Robin Robinson, Ph.D. “We are making progress quickly to develop product candidates for clinical evaluation and to make products available that protect against this virus.”
If the contract is extended, the company would conduct additional manufacturing work and other studies required to apply for U.S. Food and Drug Administration approval.
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.
