Brincidofovir: Preliminary Phase III data

Preliminary data from 48 evaluable pediatric and adult patients with adenovirus infection in the pilot portion of the open-label, U.S. Phase III AdVise trial showed that twice-weekly brincidofovir for 12 weeks led to a mortality rate of 35% compared to a historical rate of 80% in the first month after diagnosis. Median duration of observation for living patients was 57 days. Chimerix said a majority of patients also had suppression or clearance of adenovirus from their blood. In 26 evaluable patients with <2 months of follow up, brincidofovir led to undetectable viral loads in 14 of 23 patients with viremia at study entry. Of the 26 evaluable patients, 12 died. Data were presented at the Infectious Diseases Society of America meeting in Philadelphia. Chimerix said it is working with FDA on the design of the pivotal portion as a continuation of AdVise. ...