Chimerix completes phase I study and starts phase II multi-dose trial for CMX001

Jan 6 2009

Chimerix, Inc., a biotechnology company developing orally available antiviral therapeutics, has announced that the Company has completed a single and multi-dose Phase I study of CMX001 in healthy volunteers.

This study supports the further development of the drug for multiple dsDNA infections. The Company has initiated the first Phase II multi-dose clinical trial in patients.

"The safety and high oral availability demonstrated by CMX001 in the Phase I trial has exceeded our original expectations," said Dr. George Painter, Chimerix President and CEO. "We believe that CMX001 has potential for prevention and treatment of many serious and potentially fatal infections such as smallpox, cytomegalovirus, BK virus and adenovirus."

The Phase I study of CMX001 was a blinded, randomized, placebo-controlled study that evaluated the safety and pharmacokinetics of orally administered CMX001 in healthy volunteers. The study found CMX001 to be well tolerated at all doses in 84 healthy volunteers.

The first Phase II trial will study the effects of multiple doses of CMX001 given to stem cell and kidney transplant recipients with BK viruria, a condition which may eventually lead to loss of the kidney graft, or to uncontrolled bleeding in the bladder. Further studies are planned to explore the ability of CMX001 to prevent cytomegalovirus disease, a viral disease that may lead to blindness or severe gastrointestinal disease after bone marrow transplant.

CMX001 is being developed for the treatment of smallpox infection and other double stranded DNA virus infections that cause significant human morbidity and mortality. A safe, orally active antiviral drug to treat smallpox infection is needed to help people who become ill after exposure to the disease or those who cannot be vaccinated. The work is partially funded by a $36.1 million grant awarded to the company by the National Institute of Allergy and Infectious Diseases.