Chimerix

Clinical Trials

Chimerix has established a pipeline of therapeutics addressing life-threatening viral diseases. Our lead compound, CMX001, is currently being developed to treat dsDNA viruses – potentially deadly diseases for immunocompromised patients. A second compound, CMX157, is being advanced to treat human immunodeficiency virus (HIV). In addition, we have identified highly active compounds against hepatitis C and influenza. We are also screening our proprietary Chimerix Chemical Library for compounds with activity against dengue virus, malaria and tuberculosis.

CMX001-201 Phase 2 Trial

CMX001 has completed a Phase 2 randomized, double-blind, placebo-controlled, dose-escalation study designed to assess the safety, tolerability and ability of CMX001 to prevent or control cytomegalovirus (CMV) infection in 230 hematopoietic cell transplant (HCT) recipients (Study 201). CMV, a member of the herpesvirus family of dsDNA viruses, is present in more than two-thirds of the population and typically causes manageable disease in individuals with responsive immune systems. However, in immunosuppressed and immunocompromised transplant recipients, CMV is a major cause of morbidity and mortality.

CMX001-202 Phase 2 Trial (AdV HALT Trial)

CMX001 is being studied in a randomized, placebo-controlled, Phase 2 trial evaluating the safety and efficacy of preemptive treatment with CMX001 versus placebo for the prevention of adenovirus (AdV) disease in 48 pediatric and adult hematopoietic cell transplant (HCT) recipients with asymptomatic AdV viremia (Study 202). Adenoviruses are responsible for respiratory diseases, including pneumonia and bronchitis, as well as other infections, including gastroenteritis and acute diarrheal diseases. In immunocompromised patients who have undergone HCT, AdV infections are recognized as a significant cause of morbidity and mortality. Immunocompromised pediatric HCT patients are particularly susceptible to serious and/or fatal AdV infections. The U.S. FDA has granted CMX001 Fast Track designation status for the AdV development program.

CMX157

CMX157 demonstrated a favorable safety, tolerability and drug distribution profile in a first-in-human clinical trial. The Phase 1 study was a randomized, blinded, single dose, dose-escalation trial to evaluate safety, tolerability and pharmacokinetics of CMX157 in healthy volunteers.