The decision to advance VX-659 and VX-445 into Phase 3 development was based on initial Phase 2 data, including new data from ongoing Phase 2 studies.
The studies showed mean absolute improvements in percent predicted forced expiratory volume in one second (ppFEV1) of up to 13.3 and 13.8% 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).
The triple combination regimens were generally well tolerated across both studies, and the majority of adverse events were mild to moderate in severity. Across the studies, the discontinuation rate due to adverse events was low.
Regulatory discussions are ongoing to finalize the design of Phase 3 programs for VX-659 and VX-445.
Vertex invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases.
In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.
The company has research and development sites and commercial offices in the United States, Europe, Canada, and Australia.
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