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.