Vertex completes enrollment of Phase III studies of VX 659 triple combination to treat cystic fibrosis in people with F508del mutations.

Vertex Pharmaceuticals Incorporated has announced that enrollment is complete for the two Phase III studies of the next-generation corrector VX 659 in triple combination with tezacaftor and ivacaftor in people with cystic fibrosis (CF) with one F508del mutation and one minimal function mutation and in people with two F508del mutations . Based on the completion of enrollment, Vertex expects to report data from both Phase III studies of the VX 659 triple combination regimen in late 2018.

Vertex expects to complete enrollment of the two Phase III studies of the next-generation corrector VX 445 in triple combination with tezacaftor and ivacaftor in the fourth quarter of 2018 and to report data from these studies in the first quarter of 2019. Vertex plans to evaluate data from both the VX 659 and VX 445 Phase III triple combination programs to choose the best regimen to submit for potential regulatory approval. The data expected in late 2018 for VX 659 and in the first quarter of 2019 for VX 445 are expected to provide the basis for submission of a New Drug Application (NDA) to the FDA for people with one F508del mutation and one minimal function mutation no later than mid-2019.