DURHAM, N.C., June 07, 2016 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals in areas of high unmet medical need, today announced that M. Michelle Berrey, M.D., M.P.H., President and Chief Executive Officer of Chimerix, will participate in a panel focused on North Carolina’s role in biodefense preparation at the “Medical, Biomedical and Biodefense: Support to the Warfighter Symposium” being held June 7-8, 2016 in Research Triangle Park, North Carolina.
Chimerix’s lead product candidate, brincidofovir, is in development for the prevention and treatment of viral infections, including smallpox. Following a global vaccination campaign, the World Health Organization (WHO) declared smallpox eradicated in 1980. Routine smallpox vaccination programs were discontinued in the early 1970s, leaving the general population with waning or no immunity. Smallpox viral stocks are known to remain for research purposes in the U.S. and Russia and it is suspected that undeclared viral stocks also exist. Smallpox remains one of the top infectious threats to be addressed by a national public health response plan.
“In the event of a smallpox bioweapon event or accidental release, antiviral therapy would be an important element of our national response,” said Dr. Berrey. “We remain committed to the development of brincidofovir as a medical countermeasure to supplement smallpox vaccination, the first line of response following a potential bioweapon event with smallpox. Because vaccines must be administered prior to the emergence of clinical signs and symptoms, and may not be safe for millions of Americans with certain common skin conditions or compromised immune systems, brincidofovir has the potential to help fill this need.”
Brincidofovir Program for Smallpox
Brincidofovir is in development for the treatment of smallpox under the FDA's Animal Rule, which allows for the conduct of efficacy studies in animal models for conditions that are not appropriate for study in human subjects. In February 2016, Chimerix presented positive results from a pivotal study of brincidofovir in the rabbitpox model for smallpox. One hundred percent survival was demonstrated in animals that received brincidofovir immediately following onset of a clinical sign of infection. Animals that received brincidofovir one or two days after the onset of fever had a 93 percent survival rate, demonstrating a clinically relevant and statistically significant improvement compared to placebo. Given that the disease course of rabbitpox is more rapid than human smallpox (mean time from fever to death is four days in the rabbitpox model, compared with approximately two weeks in humans infected with smallpox), there may be several days during which treatment with an antiviral could provide protection following clinical evidence of smallpox infection.
Chimerix expects to conduct a second animal efficacy study with brincidofovir in the second half of 2016. A meeting with the FDA to discuss any additional data that may be required for a regulatory decision for brincidofovir for the treatment of smallpox will follow once this study is completed.
BARDA Contract for the Development of Brincidofovir for Smallpox
The Company initiated the development contract with the Biomedical Advanced Research and Development Authority (BARDA) in February 2011 to support early research and development of brincidofovir in animal models of smallpox. In September 2015, the Company executed an extension of this contract, providing approximately $13.0 million in additional funding.
This project has been funded in whole or in part with funds from BARDA, office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201100013C.
Chimerix's lead product candidate, brincidofovir, is a nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including the herpesviruses and adenoviruses. Brincidofovir has not been associated with kidney or bone marrow toxicity in over 1,000 patients treated to date. Brincidofovir has received Fast Track designation from the FDA for adenovirus, cytomegalovirus (CMV) and smallpox. Brincidofovir has also received Orphan Medicinal Product Designation for the prevention of CMV disease from the European Commission.
Chimerix is a biopharmaceutical company dedicated to discovering, developing and commercializing novel antivirals in areas of high unmet medical need. Chimerix's proprietary lipid conjugate technology has produced brincidofovir (BCV, CMX001); CMX157, which was licensed to ContraVir Pharmaceuticals in 2014; and earlier-stage clinical candidates, including CMX669. For further information, please visit Chimerix's website, www.chimerix.com.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility that there may not be a viable continued development path for brincidofovir, that FDA and other regulatory authorities may not approve brincidofovir or brincidofovir-based regimens, and that marketing approvals, if granted, may have significant limitations on their use. As a result, brincidofovir may never be successfully commercialized. In addition, Chimerix may be unable to file for regulatory approval for brincidofovir with other regulatory authorities. These risks, uncertainties and other factors could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in the Company’s filings with the Securities and Exchange Commission, including without limitation the Company’s most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.