Brincidofovir: Phase III data
Top-line data from the double-blind, international Phase III SUPPRESS trial in 452 CMV-seropositive hematopoietic stem cell transplant (HSCT) recipients showed that 100 mg oral brincidofovir twice weekly missed the primary endpoint of a lower incidence of clinically significant CMV infection at week 24 vs. placebo. Fewer patients in the brincidofovir arm had a CMV infection during the on-treatment period through week 14 after HSCT vs. placebo. However, there was an increase of CMV infections in the brincidofovir arm during the off-treatment period from weeks 14 to 24 vs. placebo. There was also a numerical increase in mortality in the brincidofovir arm vs. the placebo arm. Chimerix said that brincidofovir failed the endpoints of preventing CMV infections and mortality due to confirmed cases of graft-versus-host-disease (GVHD), which resulted in significantly higher use of corticosteroids compared to the placebo arm. The rate of discontinuation due to gastrointestinal events was <10%. Chimerix will present additional data from SUPPRESS at the BMT Tandem Meetings in Honolulu in February. ...