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news.BioCryst Pharmaceuticals has announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised additional options to conduct Phase 1 clinical human safety trials of an intramuscular formulation of BCX4430, as well as efficacy studies in non-human primates to assess effective dose ranges and dose schedules.
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These options represent an additional $4.1 million to BioCryst in order to advance the development of BCX4430 as a treatment for hemorrhagic fever viruses. NIAID, part of the National Institutes of Health, granted a contract to BioCryst in September 2013 valued up to $22.0 million over five years, if all contract options are exercised.
With these two additional options, approximately $13.5 million of funding has been awarded to date under the contract.
"The ongoing Ebola epidemic in West Africa emphasizes the urgent need for safe and effective antiviral agents for hemorrhagic fever virus diseases. With these additional funds, BioCryst can move forward with important non-human primate efficacy studies, an IND filing, and Phase 1 human trials of intramuscular BCX4430," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst.
"We look forward to the body of evidence supporting BCX4430 evolving into a highly compelling package, enabling us to attract U.S. Government advanced development funding. This is critical so that a new drug application can be filed as quickly as feasible for this unique, broad spectrum antiviral."
This project will be funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201300017C.