BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that it has delivered a written response to the request for proposal (RFP) announced on September 21, 2009 from the U.S. Department of Health & Human Services (HHS) for the supply of intravenous (i.v) peramivir for the treatment of critically ill influenza patients under Emergency Use Authorization (EUA). BioCryst management intends to provide an update once the RFP process has reached a conclusion.
In addition, BioCryst announced it is initiating two Phase 3 studies of i.v. peramivir for the treatment of hospitalized patients with serious influenza. These studies are intended to support U.S. regulatory approval of peramivir as a treatment for influenza. Expenses for these Phase 3 studies are covered under the recently modified $180 million HHS/Biomedical Advanced Research and Development Authority (BARDA) contract to develop peramivir for the treatment of influenza.
"The novel H1N1 2009 virus is already producing significant morbidity and mortality within North America, and I expect the burden on the healthcare system to increase in the coming weeks," said Michael Ison, M.D. MS, Assistant Professor at Northwestern University Feinberg School of Medicine and lead investigator for one of the studies. "This Phase 3 study will provide an important opportunity to evaluate peramivir in an area of unmet medical need for seriously ill patients in the hospital setting."
According to the U.S. Centers for Disease Control & Prevention (CDC), on average 5 to 20 percent of the population gets the flu in the U.S.; more than 200,000 people are hospitalized from flu complications and about 36,000 people die from flu-related causes.
"BioCryst is pleased to be able to proceed with the first phase 3 studies of an anti-viral agent ever conducted in influenza patients requiring hospitalization," said Dr. William P. Sheridan, Chief Medical Officer at BioCryst. "The need for such studies is clear; there are currently no anti-viral agents approved for this seriously ill patient population, and no intravenous or injectable forms of any anti-viral agent are approved for any influenza indication."
One Phase 3 study is a multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of i.v. peramivir administered once-daily for five days in addition to standard of care (SOC), compared to standard of care alone, in adults and adolescents who are hospitalized due to serious influenza. The other Phase 3 study is an open-label, randomized study of the anti-viral activity, safety and tolerability of i.v. peramivir 600 mg administered once-daily compared with split doses twice-daily for five days in adult and adolescent hospitalized subjects with confirmed or suspected influenza infection. The combined enrollment target for these studies is approximately 700 patients. Further details regarding these Phase 3 study designs are available at clinicaltrials.gov at this link:
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