logo
Share SHARE
FONT-SIZE Plus   Neg

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 RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Major League Baseball is talking expansion for the first time in a few decades. Owners stand to make a pretty penny from expansion fees and subsequent television rights. The possibility of a more balanced schedule is also enticing. Strong expansion candidates in the U.S. and Canada are ready... The New York Times is teaming up with Google again to give away Google Cardboard, the virtual reality headsets, but this time only to its "most loyal" digital subscribers. The company said that the digital-only subscribers selected for this distribution were chosen based on the duration of their subscriptions. Oil company Exxon Mobil Corp. on Friday reported a 63 percent fall in profit for the first quarter from last year, while Chevron Corp. reported a loss for the quarter, both on lower revenues. The results were impacted by the fall in crude oil prices and weaker refining margins. However, Exxon Mobil's earnings beat analysts' estimates, while Chevron's loss was wider than their expectations.
comments powered by Disqus
Follow RTT