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Vertex Initiates First Phase 3 VX-659 Triple Combination Study in Certain People with Cystic Fibrosis


Vertex Initiates First Phase 3 Study of VX-659, Tezacaftor and Ivacaftor as an Investigational Triple Combination Regimen for Certain People with Cystic Fibrosis


February 21, 2018

Vertex announced the initiation of the first Phase 3 study of VX-659, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation. The study will enroll 360 patients ages 12 and older and the primary endpoint of the study is the mean absolute change from baseline in percent predicted forced expiratory volume in one second (ppFEV1) at Week 4 of treatment. The study is designed to support the potential submission of a New Drug Application in the U.S. Learn more about this investigational program here.