Chimerix and US Army collaborate on smallpox vaccine

The participants in the collaboration will evaluate the therapeutic in animal models maintained by the researchers at the US Army Medical Research Institute of Infectious Diseases (USAMRIID).

The development of CMX001 falls under the animal efficacy rule of the FDA, which defines criteria for licensing agents directed against certain serious or life-threatening conditions, such as smallpox, that cannot be directly studied in humans.

Agents developed under the animal efficacy rule are tested in humans for safety, but are tested for effectiveness in animals, usually in two species. The agreement with USAMRIID will provide Chimerix with the opportunity for testing CMX001 and other potential drug candidates in USAMRIID’s animal models of smallpox and monkey pox infection.

“Smallpox continues to pose a significant bioterrorism threat, yet to date there is no effective oral drug for the virus and an estimated 40 million people in America alone cannot be safely vaccinated,” said Dr George Painter, Chimerix CEO. “This agreement with USAMRIID is critical to the development of CMX001.”

Smallpox was eradicated in 1979 through the efforts of the World Health Organization (WHO). Currently, infectious variola, the causative agent of smallpox, is known to exist only in two WHO-sanctioned repositories, one in Russia and the other at the Centers for Disease Control and Prevention (CDC) in Atlanta. However, there is concern that undisclosed reference stocks of the virus may exist-and given its potential as a biological threat agent, development of smallpox therapeutics is a high priority.