From VRTX.com:
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.
Click on link to see which CFTR Mutations are Eligible for Phase 3 Study of Investigational VX-659 Triple Combination
in People with One F508del Mutation and One Minimal Function Mutation
https://www.vrtx.com/sites/default/files/VX659Ph3MFmutations.pdf
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.
Click on link to see which CFTR Mutations are Eligible for Phase 3 Study of Investigational VX-659 Triple Combination
in People with One F508del Mutation and One Minimal Function Mutation
https://www.vrtx.com/sites/default/files/VX659Ph3MFmutations.pdf