RESEARCH TRIANGLE PARK, N.C., Jan. 6 Chimerix, Inc., abiotechnology company developing orally available antiviral therapeutics,announced today that the Company has completed a single and multi-dose Phase Istudy of CMX001 in healthy volunteers. This study supports the furtherdevelopment of the drug for multiple dsDNA infections. The Company hasinitiated the first Phase II multi-dose clinical trial in patients.
"The safety and high oral availability demonstrated by CMX001 in the PhaseI trial has exceeded our original expectations," said Dr. George Painter,Chimerix President and CEO. "We believe that CMX001 has potential forprevention and treatment of many serious and potentially fatal infections suchas smallpox, cytomegalovirus, BK virus and adenovirus."
The Phase I study of CMX001 was a blinded, randomized, placebo-controlledstudy that evaluated the safety and pharmacokinetics of orally administeredCMX001 in healthy volunteers. The study found CMX001 to be well tolerated atall doses in 84 healthy volunteers.
The first Phase II trial will study the effects of multiple doses ofCMX001 given to stem cell and kidney transplant recipients with BK viruria, acondition which may eventually lead to loss of the kidney graft, or touncontrolled bleeding in the bladder. Further studies are planned to explorethe ability of CMX001 to prevent cytomegalovirus disease, a viral disease thatmay lead to blindness or severe gastrointestinal disease after bone marrowtransplant.
CMX001 is being developed for the treatment of smallpox infection andother double stranded DNA virus infections that cause significant humanmorbidity and mortality. A safe, orally active antiviral drug to treatsmallpox infection is needed to help people who become ill after exposure tothe disease or those who cannot be vaccinated. The work is partially fundedby a $36.1 million grant awarded to the company by the National Institute ofAllergy and Infectious Diseases.
Chimerix, Inc. discovers, develops and commercializes therapeutics withenhanced pharmaceutical properties that are active against a broad range ofviral diseases. Leveraging a powerful lipid, prodrug technology,ProLipTag(TM), Chimerix is able to develop drug candidates withoral-availability, increased potency and targeted delivery. These enhancedpharmaceutical properties can be applied to new drug moieties or known drugsto improve dosing parameters, broaden therapeutic applications and decreasethe risk of adverse events.
SOURCE Chimerix, Inc.