Chimerix Initiates Phase 3 SUPPRESS Trial of Brincidofovir
Chimerix, Inc. (NSDAQ: CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced initiation of dosing in the Phase 3 SUPPRESS trial (ClinicalTrials.gov ID: NCT01769170). SUPPRESS is evaluating brincidofovir (CMX001) for the prevention of cytomegalovirus (CMV) infection, the most significant infectious disease in hematopoietic cell transplant (HCT) recipients. Brincidofovir is an investigational oral nucleotide analog lipid-conjugate that has demonstrated activity against all pathogenic double-stranded DNA (dsDNA) viruses, including herpesviruses, adenoviruses, and polyomaviruses.
"Initiation of our Phase 3 SUPPRESS trial marks a significant milestone in the development program for brincidofovir," said Kenneth I. Moch, President and CEO of Chimerix. "A well-tolerated and effective prevention for CMV disease in hematopoietic cell transplant patients remains an important unmet medical need, as existing antiviral therapies are limited by significant hematologic and renal toxicities."
SUPPRESS is designed to demonstrate the efficacy and safety of brincidofovir for the prevention of CMV infection versus a placebo control, as no therapy is currently approved for the prevention of CMV in HCT recipients. The primary endpoint for SUPPRESS is prevention of clinically significant CMV infection through the first 24 weeks post-transplant. The trial is powered to detect a relative 50%