BioCryst Reports Positive Results From Phase II Study of Influenza Drug
Posted on: Wednesday, 30 July 2008, 03:00 CDT
BioCryst Pharmaceuticals has announced positive preliminary results of a Phase II study of intravenous peramivir administered via a single dose injection in the outpatient setting for the treatment of seasonal influenza.
The Phase II study was a randomized, double-blind, placebo-controlled trial, which enrolled 300 subjects who had a positive rapid antigen test indicating acute influenza illness. Subjects were randomized to receive an i.v. injection of placebo or one of two doses of peramivir (300mg and 600mg) as a single dose administered within 48 hours of symptom onset.
The trial, conducted by BioCryst's partner, Shionogi & Co, in Japan, met its primary endpoint of improvement in the median time to alleviation of symptoms in subjects with confirmed, acute, uncomplicated influenza infection, compared to placebo alone. This result was statistically significant.
Further, safety assessments confirmed that peramivir was generally well-tolerated. Based on the study's preliminary results, Shionogi has commenced preparations for a Phase III trial of i.v. peramivir in the outpatient setting.
Jon Stonehouse, president and CEO of BioCryst, said: "As recently announced, we have initiated a Phase II study of intramuscular peramivir in a similar setting as the Shionogi study, which will add further confirmation of this promising compound's role in addressing seasonal influenza."
Source: Datamonitor
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