Chimerix Announces Emergency Investigational NDA For Brincidofovir

(RTTNews) - Chimerix, Inc. (CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, said that brincidofovir has been provided for potential use in patients with Ebola Virus Disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications or EIND were granted by the U.S. Food and Drug Administration or FDA.

Michelle Berrey, M.D., M.P.H., President and Chief Executive of Chimerix noted, "Based on in vitro data from work conducted by the CDC and the National Institutes of Health suggesting brincidofovir's activity against Ebola, we are hopeful that brincidofovir may offer a potential treatment for Ebola Virus Disease during this outbreak. Data collected over years of clinical development of brincidofovir have allowed us to progress this compound into Phase 3 programs for cytomegalovirus and adenovirus infections, and provided information on the safety and dosing of brincidofovir to allow it to be explored as a potential therapy for Ebola Virus Disease."

Chimerix is closely working with the FDA to finalize a study protocol early this week to assess the safety, tolerability, and efficacy of brincidofovir in patients who are confirmed to have an infection with the Ebola virus. Testing at the Viral Special Pathogens Branch of the CDC and the NIH revealed in vitro (test tube) activity of brincidofovir against the Ebola virus that was similar to that seen in test tube assessments of brincidofovir against other viral diseases, such as adenovirus and smallpox.

Chimerix's lead product candidate, brincidofovir, is an oral nucleotide analog that has shown broad-spectrum in vitro antiviral activity against all five families of DNA viruses that affect humans, including viruses in the herpes virus family and adenovirus.