ARTICLE | Clinical News

Vertex starts Phase III of CF triple combo

March 2, 2018 7:12 PM UTC

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) began a Phase III trial to evaluate a triple combination of VX-659, tezacaftor and Kalydeco ivacaftor in 100 cystic fibrosis patients ages 12 and older with two copies of the delta F508 mutation. VX-659 is a next-generation corrector of CF transmembrane conductance regulator (CFTR); tezacaftor is a CFTR corrector; and Kalydeco is a CFTR potentiator.

The primary endpoint of the double-blind, placebo-controlled trial is the mean absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) at week four. Secondary endpoints include safety, sweat chloride levels and patient-reported outcomes...