Phase 3 study of peramivir for the treatment of influenza
BioCryst Pharmaceuticals announced top-line results from one of its two Phase 3 studies of intravenous (i.v.) peramivir for the treatment of patients hospitalized with influenza. The completed study (“303”) was an open-label, randomized trial of the anti-viral activity, safety and tolerability of i.v. peramivir administered either as a once-daily infusion of 600mg or a twice-daily infusion of 300mg to adult and adolescent subjects hospitalized with confirmed or suspected influenza infection. Treatment was planned for 5 days with an extension to 10 days in patients who needed additional treatment. The study enrolled 234 patients aged 14 to 92 years during the 2009-2010 H1N1 pandemic of whom 200 patients (85%) had a duration of illness of more than 48 hours. The primary endpoint of the study was the change in influenza virus titer in nasopharyngeal samples, measured by log10 tissue culture infective dose50 (TCID50). Forty-four patients had a positive baseline culture, 20 for the 300mg twice-daily group and 24 for the 600mg once-daily group. Similar reductions in log10 TCID50 viral titer were observed over the first 48 hours in the two treatment groups, -1.66 (95% CI -2.32, -0.61) for 300mg peramivir twice-daily and -1.47 (95% CI -1.89, -0.75) for peramivir 600mg once-daily.
Peramivir is an intravenously administered investigational anti-viral agent that rapidly delivers high plasma concentrations to the sites of infection.
For more information call (205) 444-4600 or visit www.biocryst.com/peramivir.