Chimerix, the antiviral drug company that last week filed for an initial public offering of stock, is now on a faster regulatory path for its lead drug candidate.
The Food and Drug Administration’s “fast track” designation for CMX001 gives the Research Triangle Park company’s compound priority review. That faster review is reserved for new drugs addressing serious or life threatening conditions that have few if any alternative treatments. CMX001 is a compound that Chimerix is developing to prevent cytomegalovirus (CMV) infection, 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 in a phase II study evaluating the antiviral as a way of preventing adenovirus disease, an infection that has 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.
Chimerix filed for an IPO on March 8, seeking to raise up to $85 million. In the filing, the company said proceeds would be used for more research and development.