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BioCryst Reports Results From the First-Ever Completed Active-Controlled Phase 2 Study in Hospitalized Influenza
Date:10/27/2008

Management to Host Conference Call at 8:30 a.m. Eastern Time Today to

Discuss Results

BIRMINGHAM, Ala., Oct. 27 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced results of an exploratory Phase 2 trial of intravenous (i.v.) peramivir, a neuraminidase inhibitor, in patients hospitalized for acute serious or potentially life-threatening influenza. The Phase 2 trial compared the efficacy and safety of five days of therapy with either 200 mg i.v. peramivir per day, 400 mg i.v. peramivir per day or 75 mg oral oseltamivir twice a day, in patients who required hospitalization related to influenza. These results will be submitted to an upcoming medical meeting.

The primary objective of the study was to evaluate time to clinical stability, which is a composite endpoint comprised of normalization of temperature, oxygen saturation, respiratory rate, systolic blood pressure and heart rate. This type of endpoint has previously been used in pneumonia studies, but not in influenza. Secondary objectives of the study included evaluation of viral shedding, mortality, clinical relapse and time to resumption of usual activities.

In the primary efficacy population, for all groups combined, the study demonstrated a median of 25.3 hours to clinical stability, a median of 2.0 log reduction in time weighted change from baseline in viral titer, zero mortality, no clinical relapse and a median of 10.8 days of time to resumption of usual activities. There were no statistically significant differences in any of the efficacy endpoints between the three treatment arms. Peramivir was generally safe and well-tolerated at these dose levels.

"This landmark study provides us gre
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SOURCE BioCryst Pharmaceuticals, Inc.
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