Chimerix’s Ebola Drug to See Clinical Trials

October 15, 2014

Drugmaker Chimerix said it may soon start testing its broad-spectrum antiviral drug brincidofovir against the Ebola virus, after the FDA last week approved the company’s emergency investigational new drug application.

The Durham, N.C.,-based company supported its IND with in vitro assessments of brincidofovir against Ebola conducted by the Centers for Disease Control and Prevention and the National Institutes of Health, as well as ongoing animal testing. Chimerix said it is still working with the FDA on a protocol for an Ebola trial, but didn’t say when such a trial might begin.

The company, however, said it is hopeful that brincidofovir may offer a potential treatment for Ebola virus disease during this outbreak. It already has provided the drug to Thomas Eric Duncan, the patient who died last Tuesday in Dallas and to Ashoka Mukpo, an NBC cameraman who is being treated in Nebraska. 

Chimerix could not be reached for comment on whether Duncan and Mukpo received the drug under the FDA’s expanded access program and whether it plans to continue providing the drug to other patients outside any clinical trials.

Brincidofovir also is now being tested in a Phase III trial for cytomegalovirus, which Chimerix hopes will support a regulatory filing for preventing CMV infection in adult hematopoietic cell transplant (HCT) recipients. Another Phase III trial, this time for adenovirus, is currently enrolling patients. — Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.