Chimerix, FDA agree on trial for brincidofovir

Late Tuesday, infectious disease company Chimerix Inc. (NASDAQ:CMRX) said it and FDA agreed on an open-label pilot trial to provide access to the biotech's brincidofovir ( CMX001) to treat adenovirus infections in immunocompromised patients. Chimerix said it is also working with the agency on the design of a pivotal Phase III trial that would be a continuation of the open-label trial, which will enroll 20 patients. The first patient in the trial will be pediatric cancer patient Josh Hardy, who developed an adenovirus infection after a bone marrow transplant. An IV drug marketed for adenovirus infections led to kidney damage, and Hardy's doctors at St. Jude's Children's Research Hospital petitioned Chimerix for compassionate-use access to the company's oral brincidofovir.

Chimerix President and CEO Kenneth Moch had originally said making brincidofovir available outside of the company's trials "has the potential to slow or derail" Chimerix's ability to make the compound "available as soon as possible to the thousands of patients each year who might benefit from it." Hardy's family subsequently launched a media campaign seeking compassionate-use access to the compound. Chimerix said Hardy's story "helped accelerate a discussion" between FDA and the company on the "need for additional clinical development" for brincidofovir in adenovirus infection. ...