RESEARCH TRIANGLE PARK, NC, USA I December 30, 2013 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised an option to conduct the investigational new drug (IND) enabling program and to submit an IND. This option represents an additional $2.5 million to BioCryst in order to advance the development of BCX4430 as a treatment for Marburg virus disease. NIAID, part of the National Institutes of Health, granted an initial award of $5.0 million to BioCryst in September 2013. The total funding could be up to $22.0 million over five years and advance the program through Phase 1 trials, if all contract options are exercised.
“With these additional funds, BioCryst will rapidly initiate IND-enabling studies of intramuscular BCX4430,” said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. “This is an important next step in moving the development program forward to an IND submission, leading to an initial safety trial in healthy human volunteers.”
The goals of this contract are to file IND applications for intravenous and intramuscular BCX4430 for the treatment of Marburg virus disease, and to conduct Phase 1 human clinical trials.
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.
About the BSAV Program & BCX4430
The objective of BioCryst’s BSAV research program is to develop broad-spectrum parenteral and oral therapeutics for viruses that pose a threat to health and national security. The lead BSAV compound is BCX4430, an RNA dependent-RNA polymerase inhibitor that has demonstrated broad-spectrum activity for multiple viruses and a favorable preliminary preclinical safety profile. BioCryst is developing BCX4430 in collaboration with U.S. Government Agencies following the Animal Rule regulatory pathway.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and rare diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst’s core development programs include BCX4161 and two next generation oral inhibitors of plasma kallikrein for hereditary angioedema; peramivir, a viral neuraminidase inhibitor for the treatment of influenza; and BCX4430, a broad spectrum antiviral for hemorrhagic fevers. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 116
RESEARCH TRIANGLE PARK, NC, USA I December 30, 2013 I BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced that the National Institute of Allergy and Infectious Diseases (NIAID) has exercised an option to conduct the investigational new drug (IND) enabling program and to submit an IND. This option represents an additional $2.5 million to BioCryst in order to advance the development of BCX4430 as a treatment for Marburg virus disease. NIAID, part of the National Institutes of Health, granted an initial award of $5.0 million to BioCryst in September 2013. The total funding could be up to $22.0 million over five years and advance the program through Phase 1 trials, if all contract options are exercised.
“With these additional funds, BioCryst will rapidly initiate IND-enabling studies of intramuscular BCX4430,” said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. “This is an important next step in moving the development program forward to an IND submission, leading to an initial safety trial in healthy human volunteers.”
The goals of this contract are to file IND applications for intravenous and intramuscular BCX4430 for the treatment of Marburg virus disease, and to conduct Phase 1 human clinical trials.
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.
About the BSAV Program & BCX4430
The objective of BioCryst’s BSAV research program is to develop broad-spectrum parenteral and oral therapeutics for viruses that pose a threat to health and national security. The lead BSAV compound is BCX4430, an RNA dependent-RNA polymerase inhibitor that has demonstrated broad-spectrum activity for multiple viruses and a favorable preliminary preclinical safety profile. BioCryst is developing BCX4430 in collaboration with U.S. Government Agencies following the Animal Rule regulatory pathway.
About BioCryst Pharmaceuticals
BioCryst Pharmaceuticals designs, optimizes and develops novel small molecule drugs that block key enzymes involved in infectious and rare diseases, with the goal of addressing unmet medical needs of patients and physicians. BioCryst’s core development programs include BCX4161 and two next generation oral inhibitors of plasma kallikrein for hereditary angioedema; peramivir, a viral neuraminidase inhibitor for the treatment of influenza; and BCX4430, a broad spectrum antiviral for hemorrhagic fevers. For more information, please visit the Company’s website at www.BioCryst.com.
SOURCE: BioCryst Pharmaceuticals
Post Views: 116
