The study, expected to enroll approximately 50 patients, will evaluate the safety, tolerability and pharmacokinetics of escalating single and multiple doses of VX-770 in healthy volunteers, and also will evaluate single doses of VX-770 in patients with cystic fibrosis (CF).
Vertex has also revealed that the FDA has granted fast track designation to VX-770. This designation, granted to drug candidates intended to treat serious or life-threatening conditions, indicates that the FDA will facilitate the development and may expedite the review of a drug.
In March 2006, Vertex and Cystic Fibrosis Foundation Therapeutics (CFFT) entered into a collaboration to accelerate the clinical development of VX-770.
“This first clinical study for VX-770 signifies an important milestone in the productive collaborative history that we have shared with Vertex in the discovery of novel CF therapies,” said Dr Robert Beall, president and CEO of CFFT. “We believe that compounds such as VX-770 have great potential to change the course of CF, and we are pleased to support the accelerated development of VX-770 in early clinical studies.”