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Vertex acts on successful CF trials

Vertex Pharmaceuticals is to submit regulatory applications for it VX-770 cystic fibrosis drug following successful trials

Vertex Pharmaceuticals has reported successful Phase III trials of VX-770, a medicine in development that targets the defective protein that causes cystic fibrosis (CF), and is moving to submit regulatory applications for approval in the US and Europe.

The Phase III STRIVE study was designed to evaluate VX-770 among 161 people 12 years or older with a mutation known as G551D in the CF gene. Approximately 4 per cent of people with CF have at least one copy of the G551D mutation.

The study showed rapid improvements in lung function (FEV1) that were sustained through 48 weeks among those who received VX-770, compared to those treated with a placebo.

The results of STRIVE showed a mean absolute improvement in lung function of 10.6 per cent through week 24 (primary study endpoint) and 10.5 per cent through week 48 (secondary study endpoint) among those treated with VX-770 (n=83). The mean relative improvement from baseline in lung function among people treated with VX-770 compared to placebo (n=78) was 16.9 per cent through week 48. Absolute and relative changes in lung function were being reported.

Significant improvements in all key secondary endpoints were observed among people who received VX-770 compared to placebo.

Dr Robert Kauffman, senior vice-president and chief medical officer for Vertex, said: "In this study, people treated with VX-770 experienced significant 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."

Adverse events that occurred more frequently among those treated with VX-770 compared to placebo were headache, upper respiratory tract infections, nasal congestion, rash, dizziness and bacteria in the sputum.

13th June 2011

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