09.09.2013 13:22:52

Chimerix Begins Dosing In Phase 3 SUPPRESS Trial Of Brincidofovir

(RTTNews) - Biopharmaceutical company Chimerix, Inc.(CMRX) Monday announced initiation of dosing in the Phase 3 SUPPRESS trial, evaluating an investigational oral nucleotide analog lipid-conjugate, brincidofovir for the prevention of cytomegalovirus or CMV infection. CMV is a member of the herpesvirus family and the most common infectious pathogen in transplant recipients. Brincidofovir has demonstrated activity against all pathogenic double-stranded DNA (dsDNA) viruses, including herpesviruses, adenoviruses, and polyomaviruses.

SUPPRESS is expected to enroll about 450 hematopoietic cell transplant recipients who are at increased risk of CMV. The trial is designed to demonstrate the efficacy and safety of brincidofovir for the prevention of CMV infection versus a placebo control. The primary endpoint is prevention of clinically significant CMV infection through the first 24 weeks post-transplant, and secondary endpoints include evidence of other dsDNA viruses, including adenovirus (AdV), varicellovirus (VZV), BK virus (BKV), and other herpesviruses such as HHV-6, which contribute to morbidity and mortality in the first year following HCT.

The company also said it recently announced top line data from a Phase 2 trial of brincidofovir for AdV infection in pediatric and high-risk adult HCT recipients.

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