BioCryst Provides Peramivir Update and Reports First Quarter 2009 Financi... (ates of the H1N1 virus were tested for s...)

BioCryst Provides Peramivir Update and Reports First Quarter 2009 Financial Results

Date:5/8/2009

ates of the H1N1 virus were tested for sensitivity to peramivir and all ten isolates were susceptible to peramivir.

Intramuscular Peramivir Phase 2 Study Results for Seasonal Influenza

BioCryst also announced preliminary results from its Phase 2 study of intramuscular (i.m.) peramivir for the treatment of seasonal influenza. While the study demonstrated a numerical trend in its primary endpoint of improvement in the median time to alleviation of symptoms (TTAS) in subjects with confirmed, acute, uncomplicated influenza infection versus placebo, the difference between the two study groups was not statistically significant.

The median TTAS was 91.1 hours for those receiving a single 600 mg injection of i.m. peramivir, compared to 106.1 hours observed in those patients receiving placebo (p=0.22). The trial indicated that peramivir was generally safe and well tolerated with a similar adverse event profile noted in the peramivir and placebo treatment groups.

"The efficacy of intravenous peramivir demonstrated in a prior study conducted by Shionogi & Company Ltd. indicates its potential as a treatment for acute uncomplicated influenza," commented Dr. William P. Sheridan, Chief Medical Officer of BioCryst. "Based on the clinical evidence of activity, safety and tolerability of peramivir, we are currently in discussions with HHS-BARDA and the U.S. Food and Drug Administration (FDA) regarding further development of i.v. peramivir as a treatment for influenza."

This Phase 2 study (BCX1812-212) was a randomized, double-blind, placebo-controlled trial conducted in influenza seasons in the Southern Hemisphere (Australia, New Zealand and South Africa) in 2008 and the Northern Hemisphere (United States) in 2008 - 2009. It enrolled 405 subjects 18 years of age or older with acute uncomplicated influenza confirmed by positive rapid antigen test, whose symptom duration was 36 hours
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SOURCE BioCryst Pharmaceuticals, Inc.
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