BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today announced completion of the planned interim analysis of the peramivir Phase 3 trial in patients admitted to the hospital with serious influenza. The difference between peramivir and control groups for the primary endpoint was small and the recalculated sample size was greater than the predefined futility boundary of 320 subjects. Based on this information, the independent data monitoring committee (DMC) recommended that the study be terminated for futility. No unexpected adverse events were identified and the DMC expressed no concerns about the safety of peramivir.
“The goal of this analysis was to reassess the sample size required for the trial, and to make adjustments to the study if necessary. Based on the DMC recommendation, we have suspended enrollment of patients in the trial,” said Dr. William P. Sheridan, Senior Vice President & Chief Medical Officer of BioCryst Pharmaceuticals. “We are proceeding with a full analysis of unblinded data from the trial, and a final decision will be made following completion of the analysis and further discussions with our development partners; however, it is unlikely that peramivir development for US registration will continue.”
BioCryst has shared the DMC recommendation with the U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (HHS/BARDA) and other development partners.
The interim analysis will be discussed by BioCryst management during the Company’s third quarter 2012 results conference call and webcast on Thursday, November 8, 2012 at 8:30 a.m. Eastern Time.Phase 3 Development of Peramivir The peramivir Phase 3 U.S. registration trial (“301”) is a multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of 600 mg i.v. peramivir administered once-daily for five days in addition to standard of care (SOC), compared to SOC alone, in adults and adolescents who are hospitalized due to serious influenza. In February 2011, the primary efficacy analysis of the trial was amended to focus on a subset of approximately 160 patients not treated with neuraminidase inhibitors as SOC, in order to provide the greatest opportunity to demonstrate a statistically significant peramivir treatment effect.