Chimerix has issued a statement thanking the U.S. Food and Drug Administration (FDA) for its collaboration in developing a protocol for the immediate initiation of a 20-patient pilot trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients.
"Drug development is a complex process. At its best, it is a collaboration between FDA and Sponsors. Chimerix believes that the events of the past week demonstrate what is possible when FDA and Sponsors work closely and collaboratively.
Beginning today, Chimerix and FDA worked jointly to develop a clinical trial of open-label brincidofovir for the treatment of adenovirus infections in immunocompromised patients that would be available for Josh Hardy and other similar patients. Making a protocol available by Tuesday evening would not have been possible without the resources that both parties dedicated to this mission. Chimerix appreciates the expertise, advice and guidance that FDA provided.
Chimerix will work with the FDA to address the design of a development program that would incorporate patients similar to those who are participating in the pilot trial, to be able to provide information to support the marketing application for brincidofovir. We join the FDA in its commitment to developing safe and effective drugs for unmet medical needs."