Chimerix, Inc. today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) for the immediate initiation of a pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients. FDA has committed to work expeditiously with Chimerix on the design of a pivotal Phase 3 study that would be a continuation of this pilot study. Josh Hardy's story brought to public attention the often-devastating impact of adenovirus infection, and helped accelerate a discussion between the FDA and Chimerix regarding the need for additional clinical development to assess brincidofovir's potential in adenovirus infection. This study is expected to begin with Josh Hardy as the first patient enrolled on Wednesday, March 12, 2014.
"This 20-patient open-label study underscores Chimerix's mission to develop innovative antiviral therapies in areas of high unmet need - for everyone," said Kenneth I. Moch, President & CEO of Chimerix. "Being unable to fulfill requests for compassionate use is excruciating, and not a decision any one of us ever wants to have to make. It is essential that each individual in a health crisis be treated with equal gravity and value, a principle we have upheld by pursuing further clinical study of brincidofovir that will inform its use in adenovirus and other serious DNA viral infections."
"We are pleased to be providing access to brincidofovir in a manner consistent with our focus on progressing clinical development toward a potential regulatory approval that would make it widely available to patients who might benefit from its use," said Hervé Momméja-Marin, M.D., Vice President, Clinical Research of Chimerix. "We are grateful to the FDA for their continuous guidance and assistance in expediting brincidofovir's development path forward."