BioCryst Pharmaceuticals, Inc. has announced that the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) has awarded BioCryst a contract for the continued development of BCX4430 as a potential treatment for diseases caused by RNA pathogens, including filoviruses.
This ASPR/BARDA contract includes a base contract of $12.1 million to support BCX4430 drug manufacturing, as well as $22.9 million in additional development options that can be exercised by the Government, bringing the potential value of the contract to $35.0 million. Filoviruses represent serious threats to national security and the U.S. Government has made this a top priority for medical countermeasure development.
The scope of work under the base contract mainly focuses on drug manufacturing, including process improvement, scale up and manufacture of BCX4430 in the U.S over an 18 month period.
The BCX4430 produced under this contract is expected to be used in clinical studies and non-clinical toxicology studies supporting the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for both intravenous (i.v.) and intramuscular (i.m.) formulations of BCX4430.
"BCX4430 currently represents the only single drug that has demonstrated a survival benefit in non-human primates infected with Marburg or Ebola viruses," said Jon P. Stonehouse, President & Chief Executive Officer of BioCryst. "This new BARDA contract provides continuity in the ongoing development of our broad spectrum antiviral, '4430, and moves this program closer to the finish line."
The ASPR/BARDA contract represents the second US Government award to BioCryst for BCX4430 development. In September 2013, the National Institute of Allergy and Infectious Diseases (NIAID) awarded a contract to fund the early stage development of BCX4430, including non-human primate proof of concept studies and an ongoing randomized, placebo-controlled Phase 1 clinical trial initiated in December 2014 to evaluate the safety and tolerability of i.m. administration of BCX4430 in healthy volunteers.
Results from this trial are expected in the third quarter of 2015. $25.8 million of option funding has been awarded to date under the NIAID contract, which totals $29.1 million, if all options are exercised.