Investigational Ebola Drug Granted Emergency INDs
Chimerix announced that the Food and Drug Administration (FDA) has granted Emergency Investigational New Drug Applications (EIND) for brincidofovir as potential use in patients infected with the Ebola virus.
Brincidofovir (CMX001) is an oral nucleotide analog that demonstrates broad-spectrum in vitro antiviral activity against 5 families of DNA viruses that affect humans.
Data from in vitro studies conducted by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) suggest bincidofovir's activity against Ebola, and it may serve as possible treatment for Ebola Virus Disease during this outbreak. Testing at the Viral Special Pathogens Branch of the CDC and NIH showed in vitro activity of brincidofovir against the Ebola virus that resembled studies of brincidofovir against other viral diseases like adenovirus and smallpox.
The company is working with the FDA to finalize a clinical trial protocol this week to assess the safety, tolerability, and efficacy of brincidofovir in patients with confirmed Ebola virus infection. Further in vitro testing of brincidofovir in in vivo models of Ebola virus infection is underway.
For more information call (919) 806-1074 visit Chimerix.com.