Vertex drops part of VX-661 and ivacaftor study in CF but confident of NDA next year
Vertex Pharmaceuticals (Nasdaq: VRTX) remains confident in a Phase III development program of its investigational compound VX-661 in combination with ivacaftor for cystic fibrosis (CF), even if it is to drop part of the study.
Based on a planned interim futility analysis conducted by the study’s independent Data Safety Monitoring Board (DSMB), the US biotech firm 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 cystic fibrosis transmembrane conductance regulator (CFTR) protein function.
The analysis was conducted by the DSMB after at least eight weeks of dosing to determine whether to stop the study or to continue it and initiate enrollment in Part B.
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