Chimerix Announces Emergency Investigational New Drug Applications for Brincidofovir Authorized by FDA for Patients With Ebola Virus Disease
DURHAM, N.C., Oct. 6, 2014 (GLOBE NEWSWIRE) — Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today 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 U.S. Food and Drug Administration (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 Chief Executive Officer of Chimerix. “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 working closely with the FDA to finalize a clinical trial 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. Additional tests of brincidofovir in in vivo (animal) models of Ebola virus infection are currently underway.
About Brincidofovir (CMX001)
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 2 results in cytomegalovirus (CMV) prevention, Chimerix initiated the Phase 3 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 3 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 is also 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.
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel, oral antivirals in areas of high unmet medical need. Chimerix’s proprietary technology has given rise to brincidofovir (BCV, CMX001), a clinical-stage nucleotide analog lipid-conjugate, which has demonstrated potent antiviral activity and safety in convenient, orally administered dosing regimens. Chimerix is currently enrolling SUPPRESS, the Phase 3 study of brincidofovir for the prevention of cytomegalovirus (CMV) in hematopoietic cell transplant recipients. In addition, Chimerix is enrolling the pilot portion of the Phase 3 AdVise study of brincidofovir for treatment of adenovirus infection. Chimerix is also working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. For further information, please visit Chimerix’s website, www.chimerix.com.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Chimerix’s filings with the Securities and Exchange Commission, including without limitation its most recent Quarterly Report on Form 10-Q, its most recently filed Current Reports on Form 8-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Chimerix undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Joseph T. Schepers
Investor Relations and Corporate Communications