"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 at this link:

SOURCE BioCryst Pharmaceuticals, Inc.