Vertex Pharmaceuticals selected VX-659 and VX-445 for Phase 3 development as part of two different triple combination regimens fir people with cystic fibrosis. Phase 2 data was extrapolated into Phase 3 development.
The data imparted mean absolute improvements in percent predicted forced expiratory volume in one second (ppFEV1) of up to 13.3 and 13.8 percentage points from baseline through four weeks of treatment for the triple combination regimens with VX-659 (400mg QD) or VX-445 (200mg QD), respectively, in people who have one F508del mutation and one minimal function mutation (F508del/Min). Regulatory discussions are ongoing to finalize the design of Phase 3 programs for VX-659 and VX-445.
The triple combination regimens were generally well tolerated across both studies and the majority of adverse events signified variations.
Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical Officer at Vertex said “We look forward to concluding our discussions with regulators and initiating Phase 3 development in the first half of the year, with the goal of bringing a triple combination regimen to patients as quickly as possible.”