Chimerix’s Brincidofovir Selected for Use in Ebola Clinical Trial in West Africa by International Consortium
DURHAM, N.C., Nov. 13, 2014 (GLOBE NEWSWIRE) — Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its investigational broad-spectrum antiviral brincidofovir has been selected as one of two investigational agents to be evaluated in a clinical study in patients with confirmed Ebola Virus Disease in west Africa. Chimerix and the University of Oxford are in the process of finalizing a definitive agreement for supplying brincidofovir for the planned clinical trial.
With funding provided by the Wellcome Trust, the trial will be led by the University of Oxford on behalf of the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), with operational support in west Africa provided by Médecins Sans Frontières (MSF). The World Health Organization (WHO) and local health authorities are also participating in this clinical research. The west African trials will require the review and authorization of local health ministers and ethics boards prior to commencement.
“During what is perhaps the greatest acute public health crisis of our lifetimes, we want to recognize the profound sense of urgency and myriad scientific, medical, and clinical development issues being addressed together with multiple federal and international partners. We look forward to finalizing the trial arrangements with ISARIC as soon as possible to allow a better understanding of the potential benefit that brincidofovir could have in this Ebola Virus Disease outbreak,” said M. Michelle Berrey, M.D., M.P.H., President and Chief Executive Officer of Chimerix.
In October, the U.S. Food and Drug Administration (FDA) authorized a Phase 2 (Study 205) single-arm study to evaluate the safety and antiviral activity of brincidofovir in subjects with confirmed Ebola Virus Disease.
About Brincidofovir (CMX001)
Chimerix’s lead product candidate, brincidofovir, is an oral nucleotide analog that has shown 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 not been associated with kidney or bone marrow toxicity in over 1,000 patients treated to date, side effects that can be treatment limiting with currently available antivirals. 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. In October 2014, Chimerix received authorization from the FDA to begin a Phase 2 study to access the safety, tolerability and efficacy of brincidofovir in patients who have Ebola Virus Disease.
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 produced brincidofovir (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, a Phase 3 study of brincidofovir for the prevention of cytomegalovirus (CMV) in adult hematopoietic cell transplant (HCT) recipients. In addition, Chimerix is enrolling the pilot portion of the Phase 3 AdVise trial of brincidofovir for treatment of adenovirus (AdV) infection. Chimerix is working with BARDA to develop brincidofovir as a medical countermeasure against smallpox. Chimerix has also received authorization from the FDA to begin a Phase 2 study of brincidofovir in patients with Ebola Virus Disease. 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
Executive Director, Investor Relations and