Chimerix Antiviral Makes FDA Fast Track

CED Member Chimerix announced today that it was given priority review designation from the Food and Drug Administration (FDA) for CMX001, a compound the company is developing to prevent cytomegalovirus (CMV) infection.


Cytomegalovirus infection is an infection that can severely sicken patients with already compromised immune systems.

The antiviral works by blocking replication of double-stranded DNA (dsDNA) viruses.

Chimerix has completed phase II clinical trials studying CMX001 as a way of preventing CMV in patients undergoing hematopoietic stem cell transplant procedures. The company expects to start a phase III study later this year in patients undergoing these transplants.

CMX001 is a broad spectrum antiviral candidate that has other potential applications beyond CMV. The compound had previously been granted fast track designation for preventing adenoviral disease in patients after they undergoing hematopoietic stem cell transplants.

CMX001 is currently in a phase II study evaluating the antiviral as a way of preventing adenovirus disease, an infection for which there are no approved therapies and can be fatal.

The antiviral candidate is also being studied for applications in smallpox. Chimerix has a contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop CMX001 as a possible countermeasure against the the use of smallpox for bioterrorism.

It's a big week for Chimerix, which filed for an initial public offering on March 8. The company is seeking up to $85 million.