VX-770 is a medicine in development for people with cystic fibrosis who are 6 years or older and have at least one copy of the G551D mutation.
The study was intended to investigate VX-770 in people with at least one copy of the G551D CFTR mutation.
In this study, people who received VX-770 experienced reduction in the amount of salt in their sweat (sweat chloride concentration).
Vertex chief medical officer and senior vice president Robert Kauffman said in this study, people treated with VX-770 experienced improvements in lung function and reductions in sweat chloride within the first two weeks of treatment, and these benefits were sustained through the nearly year-long study.
"Given the significance of these findings, we are moving quickly to submit regulatory applications for approval in the US and Europe in the second half of 2011," Kauffman said.
In addition the company has also released data from 24-week Phase 3 ENVISION study that assessed VX-770 in children with CF between the ages of 6 years and 11 years old who have at least one copy of the G551D mutation.
The results from the trial suggested improvements in lung function and other measures of disease, including weight gain and a reduction in sweat chloride were observed among people treated with VX-770 compared to placebo with 24 weeks of treatment.
Further, Vertex is on track to submit global regulatory applications for approval in the US, Canada and Europe, including a new drug application (NDA) in the US and a marketing authorization application (MAA) in the European Union in the second half of 2011.