26.09.2013 14:11:37

Chimerix Reports Positive Phase 2 Results Of Brincidofovir - Quick Facts

(RTTNews) - Chimerix, Inc. (CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, published results from its Phase 2 trial CMX001-201, evaluating brincidofovir for the prevention of cytomegalovirus or CMV infection in hematopoietic cell transplant or HCT recipients, in the New England Journal of Medicine.

Brincidofovir, Chimerix's lead product candidate, is an investigational oral nucleotide analog lipid-conjugate that has shown broad-spectrum antiviral activity against double-stranded DNA viruses including CMV. The study CMX001-201 was a 230-subject, randomized, placebo-controlled, double-blind, dose-escalation study, which achieved the primary endpoint of reduction in CMV viremia and/or CMV disease for brincidofovir 100 mg twice weekly versus placebo.

Based on these positive Phase 2 results, Chimerix recently began the Phase 3 SUPPRESS trial of brincidofovir 100 mg twice weekly for the prevention of CMV infection in HCT recipients

The primary endpoint was the incidence of CMV disease during therapy or a CMV polymerase chain reaction assay result of greater than 200 copies/mL at the time of the last dose of study drug. The company said all brincidofovir doses and dose regimens showed antiviral activity when compared with placebo, with the exception of the lowest dose, 40 mg once weekly.

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