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BioCryst Reports Positive Results From a Phase 2 Study of Intravenous Peramivir for Outpatient Influenza
Date:10/28/2008

tested positive by rapid antigen test (RAT) for influenza within 48 hours of symptom onset. Of the 300 patients randomized, 296 were included in the intent-to-treat infected population; 99 received 300 mg peramivir i.v., 97 received peramivir 600 mg i.v. and 100 received placebo i.v. The primary endpoint of the study was time to alleviation of symptoms. Other endpoints included change from baseline in composite symptom score, time-weighted change in influenza virus titers from baseline to two days following infusion, pharmacokinetics and safety.

Both doses of peramivir significantly reduced the time to alleviation of symptoms in influenza patients by 32 to 33 percent compared to placebo: hazard ratios were 0.681 for 300 mg dose and 0.666 for the 600 mg dose (adjusted p=0.0046 for both comparisons). 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. In addition, change from baseline in the composite symptom score was significantly improved in both the peramivir 300 mg and 600 mg arms compared to the placebo arm, as early as 24 hours after the start of treatment (p=0.0032 and p=0.0109, respectively). There was a significant difference between peramivir 600 mg and placebo in time-weighted change in influenza virus titers from baseline to two days following infusion (p=0.0027). Peramivir was generally well-tolerated, with an adverse event profile similar to that of placebo. Pharmacokinetic profiles of i.v. peramivir in influenza patients were similar to those seen in healthy subjects.

About the Shionogi & Co., Ltd. Partnership

In February 2007, BioCryst and Shionogi & Co., Ltd. entered into an exclusive license agreement under which Shionogi obtained rights to develop and commercialize peramivir in Japan for the treatment of seasonal and potentially life-threatening human influenza. Earlier this year, Shionogi's rig
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SOURCE BioCryst Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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