Clinical Trials

The AdVise (NCT02087306) trial is a fully enrolled, open-label trial designed to evaluate the safety and efficacy of brincidofovir for the treatment of adenovirus infections in pediatric and adult patients. Chimerix is currently enrolling patients in Study 351 to provide patients with serious adenovirus infection or disease access to treatment with brincidofovir. No therapy is currently approved for the treatment of adenovirus infection in immunocompromised patients. Visit clinicaltrials.gov for trial information.

We are working with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir (CMX001) as a medical countermeasure to treat potential smallpox outbreaks in the event of bioterror attacks or accidental release. In the 100 years preceding its eradication, smallpox is estimated to have killed more than one billion people worldwide. In what may be the greatest achievement of modern medicine, smallpox was officially declared eradicated by the World Health Organization in 1980 following a global vaccination campaign. Declared smallpox stocks remain, for research purposes, in freezers in the United States and Russia; however, undeclared stocks are suspected in a number of other countries as well. Due to adverse effects associated with the vaccine, routine vaccination ceased long ago. Because smallpox has been absent from the population for many years, our population could be highly susceptible to an outbreak. Brincidofovir was originally selected for pharmaceutical development based on its activity against poxviruses in vitro and in animal models. In 2003, Chimerix began a partnership with the National Institute of Asthma and Infectious Diseases (NIAID) to complete the initial work needed to begin human testing. By 2011, the collaboration with NIAID had reached its conclusion and a new partnership with BARDA began, with the goal of developing brincidofovir as a medical countermeasure against smallpox. The Chimerix Smallpox Animal Efficacy Development Program is being conducted under the FDA’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. Initial results in a pivotal study in a rabbit model of smallpox have been positive, as the trial met its primary endpoint. Animals treated with brincidofovir upon the first clinical sign of disease, and animals that received brincidofovir 24 or 48 hours after the first clinical sign of disease, demonstrated a statistically significant (p < 0.05) reduction in mortality compared to rabbits that received placebo. Final results from this study, including data on the incidence and severity of clinical and laboratory events in each cohort, will be submitted to an upcoming medical conference and to the FDA for discussion of next steps.