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BioCryst Provides Update Regarding Peramivir for Influenza
Date:9/30/2009

am 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:

http://www.clinicaltrials.gov/ct2/results?term=Peramivir+HHS+Phase+3&recr=Open

About peramivir

Peramivir is an anti-viral agent that was discovered by BioCryst which inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against pandemic H1N1 swine flu origin viral strains. Peramivir has been studied in patients with complicated and uncomplicated influenza. BioCryst's partner, Shionogi & Co., Ltd. is currently preparing to file for regulatory approval in Japan this year.

About Influenza

Influenza (the flu) is a contagious respiratory illness caused by

SOURCE BioCryst Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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