In a post hoc analysis, 101 subjects showed evidence of adequate intramuscular injections as measured by a standard laboratory test, serum creatine kinase elevations over baseline. In this group of subjects, peramivir showed a larger treatment effect on the time to alleviation of symptoms. For these 101 subjects, peramivir showed an improvement of 64.8 hours over placebo at the 300mg dose, and an improvement of 44.6 hours over placebo at the 150mg dose. These differences were shown using the same measure of symptom alleviation as used for the primary endpoint, and they indicate a dose response in this group of patients.
At both doses studied, peramivir demonstrated a safety and tolerability profile similar to placebo, both in the total population and in the population showing evidence of intramuscular delivery.
"We are clearly disappointed that we did not achieve the primary endpoint across the entire study population. However, the goal of this Phase II study was to explore the efficacy of peramivir and establish its safety profile in subjects with acute influenza infections as we plan for the phase III trial. In subjects that we believe received the intended dosing of peramivir, we saw patients achieve symptom relief up to 2.6 days faster than placebo, a result that exceeded our expectations. In addition, peramivir demonstrated a safety profile similar to placebo," said Jon P. Stonehouse, President and CEO of BioCryst Pharmaceuticals, Inc. "Based on these results, we have a clear and concise plan to correct the issues identified in this study and continue our preparations to initiate our Phase III program by year end."
BioCryst will sponsor a conference call at 5:00 p.m. Eastern U.S. Time
today, Wednesday, September 19, 2007 to discuss today's news in more
detail. This call is open to the public and can be accessed live either
over the Internet from the company's website http://www
|SOURCE BioCryst Pharmaceuticals, Inc.|
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