Chimerix Presents Positive Results From Brincidofovir Pivotal Study in Animal Model for Smallpox
The study met its primary endpoint of clinically and statistically significant (p < 0.05) reduction in mortality for brincidofovir-treated animals compared with animals that received placebo. At the time of detection of fever, a clinical indication of confirmed infection, animals were randomized to receive placebo or brincidofovir administered immediately or after a 24, 48, or 72 hour delay. Animals that received brincidofovir immediately had 100 percent survival, and animals that received brincidofovir after a 24 or 48 hour delay had a 93 percent survival, statistically significant improvements compared with less than 50 percent survival in animals that received placebo. Treatment with brincidofovir begun immediately or following a 24 or 48 hour delay resulted in an immune response and a reduction in the amount of virus in the blood. These effects in the brincidofovir-treated animals may decrease the spread of infection between animals, and if confirmed in humans, brincidofovir may decrease person-to-person transmission of smallpox in a bioterror event.
"Data from this pivotal animal model study support the potential to advance brincidofovir as a medical countermeasure for smallpox. There is currently no antiviral approved to treat smallpox, considered a Category A Priority Pathogen by the
The pivotal smallpox study was conducted under the Food and Drug Administration's (FDA) Animal Efficacy Rule, which allows for testing of investigational drugs in animal models to support effectiveness in diseases which are not ethical or feasible to study in humans. In this well-characterized model of smallpox, animals were administered a lethal inoculum of rabbitpox virus and monitored for clinical signs of disease. Following the onset of the first clinical sign of disease, animals were randomized to receive placebo, immediate brincidofovir, or brincidofovir after a delay of 24, 48, or 72 hours. The primary objective of this study was to assess the efficacy of immediate and delayed treatment with brincidofovir compared with placebo in preventing mortality in animals infected with the lethal rabbitpox virus. Secondary objectives were to evaluate incidence, severity and progression of clinical events associated with rabbitpox virus infection between the brincidofovir treatment groups and placebo-treated animals.
The brincidofovir doses used in this animal study were scaled to equivalent doses used in the clinical trials of brincidofovir for CMV and adenovirus in humans. Final data from the rabbitpox study together with efficacy data from a mouse model of smallpox will be submitted to the
About Smallpox
Smallpox is estimated to have killed more than one billion people worldwide prior to its eradication in 1980 following a global vaccination campaign. Smallpox stocks remain for research purposes in
BARDA Contract for the Development of Brincidofovir for Smallpox
The Company initiated the development contract with the
This project has been funded in whole or in part with funds from BARDA, office of the Assistant Secretary for Preparedness and Response,
BARDA Procurement of Brincidofovir for the Strategic National Stockpile
In
About Brincidofovir
About
Forward-Looking Statements
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
CONTACT: Investor Relations: ir@chimerix.com orSource:Jesse Baumgartner Stern Investor Relations Jesse@sternir.com 212-362-1200 Media: Becky VonsiatskyW2O Group bvonsiatsky@w2ogroup.com 413-478-2003
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