Study confirms drug levels for IV BCV 10 mg equivalent to oral BCV 100 mg No gastrointestinal side effects seen with IV BCV at 10 and 25 mg doses DURHAM, N.C., Jan. 06, 2017 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company discovering, developing and commercializing medicines that improve outcomes for immunocompromised patients, announced preliminary data from an ongoing Phase 1 study to investigate the safety, tolerability and plasma/intracellular concentration of intravenous (IV) brincidofovir (BCV) following single escalating doses in healthy adult subjects. In this ongoing study, IV administration of BCV demonstrated a favorable tolerability profile at both doses tested to date. No drug related adverse events (AEs) or laboratory abnormalities were identified. Notably, gastrointestinal (GI) side effects were absent. Blood plasma concentrations of BCV which have previously demonstrated anti-viral potency in cytomegalovirus (CMV) prevention and adenovirus treatment were achieved with IV doses that were one tenth of those required with oral dosing. This suggests that even the lowest tested IV dose of brincidofovir should provide antiviral activity. "Data from this ongoing study suggest that brincidofovir was generally safe and well tolerated at the 10 and 25 mg doses, and achieved target plasma concentrations," said M. Michelle Berrey, MD, MPH, President and CEO of Chimerix. "These preliminary results build on our preclinical studies which showed that IV brincidofovir was associated with fewer GI side effects. We believe that IV brincidofovir represents a promising investigational option for the prevention and treatment of a broad range of life-threatening viral infections in immunocompromised patients." A total of 40 healthy subjects will be randomized to receive either a single dose of IV BCV or IV placebo in one of four cohorts. To date, 16 subjects have enrolled into 2 dose groups; 8 subjects were randomized in each of Cohorts 1 (IV BCV 10 mg) and 2 (IV BCV 25 mg). It is anticipated that two additional cohorts will be enrolled.