Chimerix Says CMX001-201 Met Primary Goal in CMV Viremia/Disease Cut

Chimerix, Inc. CMRX, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the publication of results from its Phase 2 Study CMX001-201 evaluating brincidofovir (CMX001) for the prevention of cytomegalovirus (CMV) infection in hematopoietic cell transplant (HCT) recipients. The article, entitled "CMX001 to Prevent Cytomegalovirus Disease in Hematopoietic-Cell Transplantation," appears in the September 26th issue of the New England Journal of Medicine (N Engl J Med 369:1227-36). 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 (dsDNA) viruses including CMV. Study CMX001-201, a 230-subject, randomized, placebo-controlled, double-blind, dose-escalation study, met the primary endpoint of reduction in CMV viremia and/or CMV disease for brincidofovir 100 mg twice weekly versus placebo (p=0.002). Based on these positive Phase 2 results, Chimerix recently initiated the Phase 3 SUPPRESS trial of brincidofovir 100 mg twice weekly for the prevention of CMV infection in HCT recipients. "Although prevention of CMV infection has been recognized as a superior approach to decrease CMV-related morbidity and mortality in the months following hematopoietic cell transplantation, the side effects of available antivirals have precluded their See full press release
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