the 600 mg dose). The median time to alleviation of symptoms was 59.1
hours for those receiving the 300 mg dose, 59.9 hours for those
receiving the 600 mg dose and 81.8 hours for those receiving placebo.
The study also met all secondary endpoints. Peramivir was generally
well-tolerated in the study, with a similar adverse event profile to
that of placebo. Shionogi is currently preparing to initiate a Phase 3
program with i.v. peramivir in the outpatient setting.
-- BioCryst reported results of an exploratory Phase 2 trial of i.v.
peramivir in subjects hospitalized for acute serious or potentially
life-threatening influenza. The Phase 2 trial compared the efficacy and
safety of five days of therapy with either 200 mg i.v. peramivir per
day, 400 mg i.v. peramivir per day or 75 mg oral oseltamivir twice a
day, in subjects who required hospitalization related to influenza. The
primary objective of the study was to evaluate a novel composite
endpoint, time to clinical stability, which is comprised of
normalization of temperature, oxygen saturation, respiratory rate,
systolic blood pressure and heart rate. Secondary objectives of the
study included evaluation of viral shedding, mortality, clinical relapse
and time to resumption of usual activities. In the primary efficacy
population, for all groups combined, the study demonstrated a median of
25.3 hours to clinical stability, a median of 2.0 log reduction in time
weighted change from baseline in viral titer, zero mortality, no
clinical relapse and a median of 10.8 days of time to resumption of
usual activities. There were no statistically significant differences
in any of the efficacy endpoints between the three treatment arms.
|SOURCE BioCryst Pharmaceuticals, Inc.|
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