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BioCryst Reports Positive Preliminary Results of a Shionogi & Co., Ltd. Sponsored Phase II Study of I.V. Peramivir for the Treatment of Influenza in the Outpatient Setting
Date:7/28/2008

BIRMINGHAM, Ala., July 28 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced preliminary results of a Phase II study of intravenous (i.v.) peramivir administered via a single dose injection in the outpatient setting for the treatment of seasonal influenza. The trial, conducted by BioCryst's partner, Shionogi & Co., Ltd. in Japan, met its primary endpoint of improvement in the median time to alleviation of symptoms in subjects with confirmed, acute, uncomplicated influenza infection, compared to placebo alone. This result was highly statistically significant. Further, safety assessments confirmed that peramivir was generally well-tolerated. These data will be submitted for presentation at an upcoming medical conference. Based on the study's preliminary results, Shionogi has commenced preparations for a Phase III trial of i.v. peramivir in the outpatient setting.

The Phase II study was a randomized, double-blind, placebo-controlled trial, which enrolled 300 subjects who had a positive rapid antigen test indicating acute influenza illness. Subjects were randomized to receive an i.v. injection of placebo or one of two doses of peramivir (300 mg and 600 mg) as a single dose administered within 48 hours of symptom onset.

"The Shionogi study supports clinical efficacy for i.v. peramivir in the treatment of seasonal influenza," commented Rich Whitley, M.D., Professor in the Department of Pediatrics at the University of Alabama at Birmingham. "These data allow us to optimistically anticipate the impact peramivir may have as a potential treatment for influenza in this setting. With the advent of influenza virus resistant to currently approved neuraminidase inhibitors, new therapeutic options such a
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SOURCE BioCryst Pharmaceuticals, Inc.
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