Chimerix’s Brincidofovir Flops in Phase 3 Study
A Phase 3 study of Chimerix’s oral compound brincidofovir failed to prevent cytomegalovirus infection through week 24 following blood and marrow transplants.
The study of brincidofovir, an oral nucleotide analog being evaluated in patients undergoing hematopoietic cell transplantation, was effective on a short-term basis. However, at about six months, there was an increase in CMV infections in patients who received brincidofovir, compared with control groups. Further, there was a nonstatistically significant increase in mortality, according to the company.
Chimerix officials blamed the primary endpoint failure to confirmed cases of graft-versus-host-disease, resulting in significantly higher use of corticosteroids than in the control groups. Both GVHD and use of corticosteroids are risk factors for CMV infection that occurs after discontinuation of the antiviral in HCT recipients.
Chimerix says it would pause further enrollment in Phase 3 trials for kidney transplant recipients, pending complete data from the study.