BIRMINGHAM, Ala., Sept. 19 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced preliminary findings from a Phase II study with intramuscular (i.m.) injection of peramivir, the Company's product candidate for the treatment of seasonal and life-threatening influenza.
The study was a randomized, double-blind, placebo-controlled clinical trial designed to test whether peramivir, when administered acutely in high doses intramuscularly, could reduce the duration of symptoms during seasonal influenza. 344 patients who had a positive rapid antigen test indicating acute influenza illness were randomized to receive intramuscular injections of either placebo or one of two dose levels of peramivir (150mg and 300mg) as a single dose administered within 48 hours of symptom onset. The primary endpoint of the study was the time to alleviation of symptoms in the patients with confirmed influenza infection (n=313).
While the results indicate that in the evaluable population of 313
subjects, a single dose of peramivir demonstrated a treatment improvement
over placebo, the improvement was not statistically significant. With
regard to the primary endpoint of median time to alleviation of symptoms,
the improvement over placebo was 22.9 hours with the 150mg dose (p=0.284)
and 21.1 hours with the 300mg dose (p=0.152). Based on a preliminary
review, the Company believes that due to the introduction of a shorter
injection needle in the Phase II trial compared to the Phase I trial, only
one-third of subjects received an adequate intramuscula
|SOURCE BioCryst Pharmaceuticals, Inc.|
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