Vertex Pharmaceuticals Inc. initiates phase I clinical study for VX-770, a novel, oral drug candidate that specifically targets a key mechanism underlying cystic fibrosis (CF). The study 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 CF. The study is expected to enrol more than 50 individuals.
In March 2006, Vertex and Cystic Fibrosis Foundation Therapeutics Inc. (CFFT) entered into a collaboration to accelerate clinical development of VX-770. CFFT is the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation. Vertex retains worldwide rights to develop and commercialize 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 Robert J. Beall, president and CEO of the Cystic Fibrosis Foundation and 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," he added.
"VX-770 is the first drug candidate to have emerged from our innovative CF research efforts, and the initiation of this phase I study represents an exciting new stage in the development of this compound," John Alam, executive VP, medicines development, and Chief Medical Officer of Vertex said adding, "Laboratory results for VX-770 have been highly encouraging and support the initiation of this first clinical study. We look forward to evaluating VX-770 in both healthy volunteers and patients with CF in the coming months to determine the next steps for the VX-770 development program."
The US FDA has also granted fast track designation to Vertex' VX-770.