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news.BioCryst Pharmaceuticals has initiated a Phase II study of intramuscular peramivir for the treatment of seasonal influenza.
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The double-blind, placebo-controlled, parallel group Phase II trial will compare the efficacy of a single 600mg injection of intramuscular (im) peramivir to placebo in the treatment of seasonal influenza.
The dose was selected based upon an analysis of a recently completed Phase I study of a new, more concentrated 150mg/ml formulation of im peramivir, as well as prior studies of peramivir in patients with influenza.
The primary endpoint of BioCryst’s Phase II trial is improvement in time to alleviation of symptoms in patients. Secondary endpoints include reduction in viral titers and safety and tolerability. The trial is expected to enroll approximately 320 patients and will be conducted in the Southern Hemisphere.
The Phase II study will utilize the new, more concentrated 150mg/ml formulation and needle length guidelines established in recently conducted pharmacokinetic studies.
Jon Stonehouse, president and CEO of BioCryst, said: “We are confident the results of this study will move us one step closer to offering a novel and important therapeutic option for the treatment of influenza infections.”