Innovation in Action
Our proprietary technology has given rise to brincidofovir (CMX001), a clinical-stage nucleotide analog lipid conjugate that has demonstrated broad-spectrum antiviral activity against the most important dsDNA viruses that affect humans, including adenovirus, the virus that causes smallpox (Variola) and cytomegalovirus (CMV).
Brincidofovir has received Fast Track designation from the U.S. Food and Drug Administration to speed development for the treatment of adenovirus, prevention of CMV, and the treatment of smallpox. Brincidofovir has also received Orphan Medicinal Product Designation from the European Commission for the treatment of adenovirus, the prevention of CMV disease, and for the treatment of smallpox.
Clinical Research
Chimerix has initiated the AdAPT (Adenovirus After Pediatric Transplantation) study, a comparative trial of brincidofovir (CMX001) for the treatment of adenovirus in pediatric stem cell transplant recipients. There are no therapies currently approved for the treatment of adenovirus infection in immunocompromised patients. For more information on the AdAPT trial, visit clinicaltrials.gov.
Chimerix is currently developing an intravenous formulation of brincidofovir (CMX001), which may provide the ability to prevent and treat CMV, BK virus and other viral infections.
Chimerix is working with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir (CMX001) as a medical countermeasure to treat potential smallpox outbreaks due to a bioterror event or accidental release.
The Chimerix smallpox animal efficacy development program is being conducted under the U.S. Food and Drug Administration’s Animal Efficacy Rule, which allows for testing of investigational drugs in animal models to support effectiveness in diseases that are not ethical or feasible to study in humans. Results from a study of brincidofovir in a rabbit model of smallpox showed improved survival, even when treatment was initiated during the course of disease. Learn more about the study here. The company is planning a second animal model study in mice.
The Chimerix smallpox animal efficacy development program is being conducted under the U.S. Food and Drug Administration’s Animal Efficacy Rule, which allows for testing of investigational drugs in animal models to support effectiveness in diseases that are not ethical or feasible to study in humans. Results from a study of brincidofovir in a rabbit model of smallpox showed improved survival, even when treatment was initiated during the course of disease. Learn more about the study here. The company is planning a second animal model study in mice.
Chimerix has initiated Phase 1 clinical trials with CMX521.