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www.fdanews.com/articles/75205-biocryst-initiates-phase-ib-trial-of-bcx-4208

BIOCRYST INITIATES PHASE IB TRIAL OF BCX-4208

August 9, 2005

BioCryst Pharmaceuticals announced that it has initiated a Phase Ib trial of BCX-4208, the company's second generation, transition-state analog inhibitor of purine nucleoside phosphorylase.

Being conducted in healthy volunteers, the trial is designed to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of BCX-4208.

The single-center study is being conducted as a randomized, double-blind, placebo-controlled, dose-escalating trial consisting of three dose groups. Groups of ten subjects (eight on active drug, two on placebo) will receive 0.5 mg/kg, 1.5 mg/kg or 2.5 mg/kg oral doses of BCX-4208 once daily for seven days. All doses will be administered two hours prior to breakfast after an overnight fast. The study is scheduled to enroll 30 healthy adult subjects.