Rapiacta: Phase III discontinued

BioCryst discontinued the double-blind, international Phase III BCX1812-301 trial of peramivir for futility based on a pre-planned interim analysis of 119 patients not treated with neuraminidase inhibitors as SOC. According to BioCryst, the interim analysis showed only a "small difference" on the primary endpoint of time to clinical resolution between the peramivir plus SOC and the placebo plus SOC arms. BioCryst said the goal of the interim analysis was to recalculate the sample size required for the primary endpoint analysis and make adjustments as necessary. The company said that the recalculated sample size exceeded the futility boundary of 320 patients. The trial enrolled 405 of a planned 600 patients who were hospitalized for serious influenza infection to receive SOC plus once-daily 600 mg IV peramivir or placebo for 5 days.

BioCryst said a final decision on the peramivir program will be made after conducting a full analysis of the unblinded data and after further discussions with its partners. However, the company said the most likely outcome is termination of the program. During its 3Q12 earnings conference call, BioCryst said it will also evaluate operational changes to decrease its cost structure. ...