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www.fdanews.com/articles/175496-chimerix-stops-2-phase-3-trials-of-brincidofovir

Chimerix Stops 2 Phase 3 Trials of Brincidofovir

February 26, 2016

Chimerix has axed two Phase 3 trials evaluating brincidofovir for the prevention of cytomegalovirus in subjects undergoing hematopoietic cell transplantation after the candidate failed to meet the primary endpoint.

At week 24, the proportion of patients with clinically significant infection in the brincidofovir group was statistically similar to those receiving placebo — 51 percent to 52 percent, respectively. Chimerix says the failure to meet the endpoint appears to be associated with the higher use of corticosteroids and other immune-suppressing therapies in the brincidofovir arm for the treatment of presumptive graft versus host disease.

The company says it intends to pursue Phase 2 trials of the candidate in kidney transplant recipients to confirm activity against the BK virus.