The U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) awarded approximately $12 million today 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 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,” explains 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.
Source: HHS
Obituary: In Memory of SMART4TB and Project ACCELERATE
March 14th 2025In this remembrance of SMART4TB and Project ACCLERATE, 2 global health initiatives, Heather Stoltzfus, MPH, RN, CIC, explains what they are and why they serve as a warning of what has been lost and what more could be lost in the future.
The Art of Wise Leadership in Infection Control and Quality Management
March 14th 2025Discover how wise leadership in infection control transforms challenges into opportunities, fosters teamwork, and safeguards patient safety through emotional intelligence, strategic vision, and inspiring action.
The CDC at a Crossroads: Budget Cuts, Public Health, and the Growing Threat of Infectious Diseases
March 12th 2025Budget cuts to the CDC threaten disease surveillance, outbreak response, and public health programs, increasing risks from measles, avian flu, and future pandemics while straining health care infrastructure nationwide.
Standing Up for Science: A Rally Participant’s Perspective
March 11th 2025Infection Control Today's Editorial Advisory Board member and contributing editor, Heather Stoltzfus, MPH, RN, CIC, recently joined the Stand Up for Science rally in Washington, DC. She gives a first-person perspective on the rally and the rally-goers' strong message.