BioCryst Updates Peramivir Clinical Develo... ( BIRMINGHAM Ala. Jan. 23 /- BioCry...)

BioCryst Updates Peramivir Clinical Development Plan

Date:1/23/2008

BIRMINGHAM, Ala., Jan. 23 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today provided an update on activities conducted following release of the preliminary Phase II data and outlined the resulting clinical development plan for intramuscular (i.m.) peramivir.

(Logo: http://www.newscom.com/cgi-bin/prnh/20030414/BIOCRYSTLOGO )

Following release of preliminary Phase II results in September 2007, the Company completed additional analyses of the clinical data and performed a preliminary analysis of the virologic data from this trial. The Company also conducted further pharmacokinetic (PK) studies in healthy volunteers and has had discussions with the FDA and The Department of Health and Human Services (HHS) in support of the continuing development of peramivir.

Preliminary analysis of the virologic data from the Phase II trial indicated that i.m. peramivir demonstrated statistically significant reductions in influenza virus shedding in both active treatment groups when compared to placebo, with greater reductions in the 300mg group (p<0.001). Additionally, pharmacokinetic studies have been completed that indicate that needle length impacts adequate and consistent systemic exposure to i.m. peramivir. These PK studies also provide guidance on the appropriate needle length to use in future studies to provide adequate drug exposure for subjects based upon an individual's body mass index (BMI) and gender.

Based on these clinical results and virologic data, the Company believes that a single i.m. dose of 300mg peramivir can be a potentially clinically effective dose. Given the dose-response observed between the
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