Chimerix receives Emergency Investigational NDA for Ebola
Chimerix, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has announced 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 (EIND) were granted by the FDA.
"Chimerix is committed to working with global health organizations and government agencies in the fight against the Ebola virus outbreak," said M. Michelle Berrey, M.D., M.P.H., president and CEO of Chimerix. "Based on in vitro data from work conducted by the CDC and the NIH 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 III 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 working closely with the FDA to finalize a clinical trial protocol 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. Additional tests of brincidofovir in in vivo models of Ebola virus infection are currently underway.
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. Brincidofovir has shown no evidence of kidney or bone marrow toxicity in nearly 900 patients treated to date.
Building on the positive phase II results in cytomegalovirus (CMV) prevention, Chimerix initiated the phase III SUPPRESS trial in 2013. If positive, data from SUPPRESS will support Chimerix's initial regulatory submission for brincidofovir for the prevention of CMV infection in adult hematopoietic cell transplant (HCT) recipients. Chimerix recently initiated AdVise, a phase III trial in adenovirus, which is an often-fatal viral infection with no approved treatment; enrollment is ongoing for the pilot portion of the trial.
Chimerix also is working with the Biomedical Advanced Research and Development Authority (BARDA) to develop brincidofovir as a medical countermeasure against smallpox. Brincidofovir has received Fast Track designation from the FDA for CMV, adenovirus and smallpox.