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01/19/16 4:55 PM
02/08/16 2:24 PM
Chimerix…today presented positive results from a pivotal study of its antiviral, brincidofovir, in an animal model for smallpox at the ASM Biodefense and Emerging Diseases Research Meeting in Arlington, Virginia.
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.
“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 National Institute of Allergy and Infectious Diseases (NIAID). We look forward to working closely with the FDA and BARDA to contribute to the U.S. national security and public health preparedness,” said M. Michelle Berrey, MD, MPH, President and CEO of Chimerix.
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.
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