03.31.15
BioCryst Pharmaceuticals, Inc. has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA) within the U.S. Department of Health and Human Services for the continued development of BCX4430 as a potential treatment for diseases caused by RNA pathogens, including filoviruses. This 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.
Filoviruses represent serious threats to national security and the U.S. Government has made this a top priority for medical countermeasure development.
The base contract focuses on drug manufacturing, including process improvement, scale up and manufacture of BCX4430 for clinical studies and non-clinical toxicology studies supporting the filing of a New Drug Application ( NDA ) with the FDA for both intravenous and intramuscular formulations.
"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 and 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."
A Phase I trial of BCX4430 in healthy volunteers was initiated in December 2014 to evaluate the safety and tolerability of intramuscular administration. Results from a Phase I trial are expected in 3Q15.
Filoviruses represent serious threats to national security and the U.S. Government has made this a top priority for medical countermeasure development.
The base contract focuses on drug manufacturing, including process improvement, scale up and manufacture of BCX4430 for clinical studies and non-clinical toxicology studies supporting the filing of a New Drug Application ( NDA ) with the FDA for both intravenous and intramuscular formulations.
"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 and 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."
A Phase I trial of BCX4430 in healthy volunteers was initiated in December 2014 to evaluate the safety and tolerability of intramuscular administration. Results from a Phase I trial are expected in 3Q15.
