What were the results of the first part of the Phase 2 combination trial of VX-770 and VX-809?
In June 2011, Vertex announced the results of the first part of the Phase 2 clinical trial of combinations of VX-770 and VX-809. In this trial, 62 patients age 18 and older with two copies of the Delta F508 mutation were enrolled in three groups. Two groups received VX-809 for 14 days, followed by VX-770 and VX-809 in combination for seven days. One of these groups received a higher dose of VX-770. The third group received a placebo throughout the trial. Patients who received the drugs had a positive change in sweat chloride levels. Those in the group receiving the higher dose of VX-770 (250 mg) in combination with VX-809 had a greater reduction in sweat chloride than those who took the smaller dose of VX-770 (150 mg). The study also evaluated the safety and tolerability of the combination therapy. There were no serious adverse events reported during the trial.
