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news.BioCryst Pharmaceuticals announced that the National Institute of Allergy and Infectious Diseases (NIAID) has provided additional funding for efficacy studies of BCX4430 in non-human primates to further assess effective dose regimens.
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The funding represents an additional $5.5 million to BioCryst for the development of BCX4430 as a treatment for hemorrhagic fever viruses.
The new total NIAID contract amount to advance the program through the completion of the Phase 1 clinical program could be up to $39.5 million, if all contract options are exercised. To date, approximately $35.4 million of funding has been awarded under the contract.
"With these additional funds, BioCryst will continue to evaluate dosing schedules, duration of treatment and delayed dosing from time of infection to support the selection of safe and effective human doses," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst.
"This additional support from NIAID emphasizes the importance of advancing the development of treatment options for deadly emerging infectious diseases such as Ebola virus and Marburg virus."
This project is substantially funded with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services. Since September 2013, NIAID has supported BioCryst in developing BCX4430 as a therapeutic for Ebola and Marburg viruses under Contract No. HHSN272201300017C.
In March 2015, 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) awarded BioCryst a contract, HHSO100201500007C, for the continued development of BCX4430 as a potential treatment for filoviruses. To date, the total value of the BARDA contract is $36.2 million, if all options are exercised.
BCX4430 is a broad spectrum antiviral that is advancing towards completion of a Phase 1 clinical development study of the intramuscular route of administration. BCX4430 has demonstrated survival benefits in nonclinical studies of infections with a variety of serious pathogens, including Ebola, Marburg, Yellow Fever and Zika viruses.
About the BSAV Program & BCX4430
BCX4430 is an RNA dependent-RNA polymerase inhibitor that has demonstrated broad-spectrum activity in vitro against more than 20 RNA viruses in nine different families, including filoviruses, togaviruses, bunyaviruses, arenaviruses, paramyxoviruses, coronaviruses and flaviviruses.
BioCryst is developing BCX4430 in collaboration with NIAID and the Biomedical Advanced Research and Development Authority (BARDA), following the Animal Rule regulatory pathway.