- Vertex Pharmaceuticals (NASDAQ:VRTX) initiates a Phase 3 clinical trial assessing a fixed-dose combination of VX-659 (240 mg), tezacaftor (100 mg) and ivacaftor (150 mg) in cystic fibrosis (CF) patients with two copies of the F508del mutation, the most common genetic form of the disorder.
- The primary endpoint of the 100-subject study is the mean absolute change from baseline to week four of treatment in lung function as measured by percent predicted forced expiratory volume in one second (ppFEV1).
- 50 participants will receive VX-659/tezacaftor/ivacaftor and the other 50 will receive placebo/tezacaftor/ivacaftor. An open-label extension study will be offered to all patients after the initial treatment period during which they will receive the VX-659 combination for up to 96 weeks.
- Previously: Vertex picks two new candidates to advance into late-stage development of triplet CF therapy (Jan. 31)
- Now read: Vertex: The Best Is Yet To Come
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