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news.BioCryst Pharmaceuticals has reported top-line results from one of its two Phase III studies evaluating intravenous (iv) peramivir as a treatment for patients with hospitalized with influenza.
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Peramivir is an intravenously administered investigational anti-viral agent, which delivers high plasma concentrations to the sites of infection.
The open-label, randomised, safety and virology Phase III study evaluated the safety and tolerability of iv peramivir administered either as a once-daily infusion of 600mg or a twice-daily infusion of 300mg in patients with influenza.
The study enrolled 234 patients aged 14 to 92 years, who were hospitalised with confirmed or suspected influenza infection.
The primary endpoint of the study was the change in influenza virus titer in nasopharyngeal samples, measured by log10 tissue culture infective dose50 (TCID50).
The study results showed that 44 patients had 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 seen over the first 48 hours in the two treatment groups.
Both the dose regimens were safe and well-tolerated.
An analysis of the combined intent to treat infected (ITTI) population revealed that median time to resolution of fever was 25.3 hours; time to clinical resolution was 92.0 hours; time to alleviation of symptoms was 145 hours; and time to resumption of usual activities was 26.8 days.
BioCryst chief medical officer William Sheridan said the successful completion of this safety and virology study is an important step in peramivir development, which is continuing to progress with the ongoing phase 3 efficacy study in hospitalised influenza.