Vertex reveals Phase 3 Strive study results

Strive was designed to evaluate people with a mutation in the CF gene known as G551D.

In the study, profound improvements in lung function (forced expiratory volume in one second, or FEV1) were observed through week 24, and sustained through week 48, among those who received VX-770 compared to those treated with placebo.

The primary endpoint of the study was mean absolute change from baseline compared to placebo in percent predicted FEV1 (lung function) through week 24.

Improvements in all key secondary endpoints were also observed through week 48 among those who received VX-770.

Data from the study showed a mean absolute improvement in lung function from baseline compared to placebo through week 24 of 10.6% among those treated with VX-770. Mean absolute improvement in lung function among those treated with VX-770 was 10.5% through week 48.

Vertex Pharma Global Research and Development executive vice president and chief scientific officer Peter Mueller said all primary and key secondary outcome measures in this study supported VX-770 over placebo.

"Patients’ lung function improved, they gained weight, experienced fewer respiratory symptoms and felt substantially better. Due to the significance of these data and the great need for new, more effective medicines, they will work with regulatory agencies to determine the fastest way to get VX-770 approved for people with this specific type of CF," Mueller said.