The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) recently awarded approximately $12 million to BioCryst Pharmaceuticals of Durham, North Carolina, 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 and 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.
“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.
BARDA continues to seek additional proposals for the advanced development of vaccines and therapeutics against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever. Program requirements are described in BARDA’s Broad Agency Announcement BARDA-BAA-13-100-SOL-00013 at https://www.fbo.gov.
BARDA develops and procures medical countermeasures – vaccines, medicines, diagnostics and medical equipment – that address the public health and medical consequences of chemical, biological, radiological, and nuclear incidents, pandemic influenza, and emerging infectious diseases.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. The Office of the Assistant Secretary for Preparedness and Response (ASPR) leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
For more information about advanced research and development of medical countermeasures, visit www.medicalcountermeasures.gov. Contract opportunities and awards are announced at www.fbo.gov. Learn more about Ebola at www.cdc.gov/ebola and about how to protect health in disasters at www.phe.gov.