Brincidofovir: Preliminary Phase II data

Top-line data from the exploratory, double-blind, U.S. Phase II Study 202 trial in about 48 adult and pediatric patients who had received a hematopoietic stem cell transplant (HSCT) showed that CMX001 missed the primary endpoint of reducing the composite of progression to adenovirus disease and all-cause mortality vs. placebo. Chimerix noted that the trial was exploratory due to a lack of precedent data on the incidence and conversion of adenovirus viremia to disease for study powering. The company said twice-weekly CMX001 showed a non-significant numerical benefit vs. placebo on each component of the endpoint, while once-weekly CMX001 did not show a numerical benefit vs. placebo. No new safety concerns were identified. The trial enrolled patients at an earlier stage of adenovirus infection with detectable viremia but before the appearance of symptoms of disease showed. Patients weighing <50 kg received liquid formulations of 2 mg/kg twice-weekly or 4 mg/kg once-weekly CMX001. Patients weighing >=50 kg received 100 mg twice-weekly or 200 mg once-weekly CMX001. Chimerix said it plans to review the Study 202 data with FDA in 4Q13 "in the context of a pediatric plan for CMX001." Additional data will be presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy meeting in Denver in September. ...