Vertex update on VX 661 + Kalydeco (ivacaftor) Phase III studies for Cystic Fibrosis F508del mutation.
Vertex Pharmaceuticals Incorporated provided an update on its ongoing Phase III development program of its investigational compound VX-661 in combination with ivacaftor, which includes four studies that together are expected to enroll more than 1,000 people with cystic fibrosis (CF).
Based on a planned interim futility analysis conducted by the study�s independent Data Safety Monitoring Board (DSMB), Vertex plans to stop the study of VX-661 and ivacaftor in people with one copy of the F508del mutation and one copy of a mutation that results in minimal CFTR protein function (F508del het/min). There were no safety concerns noted in the DSMB�s review of the data. Vertex also announced that enrollment is now complete in the study of VX-661 and ivacaftor in people with two copies of the F508del mutation (F508del homozygous) and that the company expects to complete enrollment in the study of people with one copy of the F508del mutation and one copy of a residual function mutation in September.
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