logo
Plus   Neg
Share
Email

Vertex Reports Interim Analysis Data From Phase 2 Study Of VX-809 And Kalydeco

Vertex Pharmaceuticals Inc. (VRTX) announced an interim analysis of data from an ongoing Phase 2 study of VX-809 and Kalydeco (ivacaftor) that showed significant improvements in lung function or FEV1 among adults with cystic fibrosis or CF who have two copies (homozygous) of the most common mutation in the cystic fibrosis transmembrane conductance regulator or CFTR gene, F508del.

A planned interim analysis was conducted after approximately half of the study patients had completed 56 days of treatment.

The company said that today's results are based on data from 37 homozygous F508del patients who completed treatment in the 56-day study and 11 patients with one or two copies of the F508del mutation who received placebo.

According to interim analysis of data, there was a statistically significant improvement in lung function (absolute change in percent predicted FEV1) across the combined treatment groups relative to baseline compared to placebo (p=0.002). Of those who received VX-809 and Kalydeco (250mg, q12h), approximately 46 percent (17/37) experienced an absolute improvement from baseline to Day 56 in lung function of 5 percentage points or more, and approximately 30 percent (11/37) experienced an absolute improvement from baseline to Day 56 of 10 percentage points or more.

The company stated that none of the patients treated with placebo (0/11) achieved a 5-percentage point or more improvement from baseline to Day 56 in lung function. Most adverse events were mild or moderate in severity and comparable between treatment and placebo groups.

The study is ongoing and complete data, including statistical analyses for all patient groups, will be available in mid-2012.

Vertex noted that it plans to start a pivotal study of VX-809 and Kalydeco in people with two copies of the F508del mutation, pending final study results and discussions with regulatory agencies.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Amazon.com Inc. (AMZN) Thursday reported a first-quarter profit that more than doubled from a year ago, driven largely by a huge 46 percent growth in revenues. Shares of the online retailer gained 6 percent in extended session. Seattle, Washington-based Amazon reported first-quarter profit of $1.63... Software giant Microsoft Corp. (MSFT), Thursday reported an increase in profit for the third-quarter that trumped analysts' estimates, driven largely by strong growth in cloud business, as the software giant continues its transition from key software business to cloud business. Redmond, Washington-based... Shares of Deutsche Bank were losing around 2 percent in German trading after the banking giant reported lower profit and revenues in its first quarter with weakness in all segments, mainly Corporate & Investment Bank. Separately, the bank announced actions to reshape its Corporate & Investment Bank and additional cost-cutting measures, including job cuts.
Follow RTT