Vertex 440 Study (PHASE 2)
Study ID number: VX15-440-101
Official Title: A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis
Therapeutic Category: CFTR Modulator
VX-440 was another "corrector" investigated to see if it can help correct some of the irregularities or deformities that the gene mutation causes. It was being studied with VX-661 (Tezacaftor) and VX-770 (Ivacaftor) to see if they can help decrease some of the effects caused by CF. It was designed to help the mutated chloride channel work more effectively which could alleviate the cycle of mucus plugging, infection, and inflammation in the lungs caused by CF.
This was the first time VX-440 was given with VX-661 & VX-770 to subjects with CF. It was given to those who are deltaF508 homozygous (have 2 copies) or heterozygous (have at least 1 copy and 1 minimal function mutation that is not likely to respond to Tezacaftor/Ivacaftor). The study was done to learn more about the safety and effects of VX-440 when given given combination with VX-661 &VX-770 to subjects with CF. This also looked at how VX-440&VX-661&VX770 may affect your body and how your body breaks down and eliminates the drugs.
The study was completed. However, it did not proceed to a phase 3 trial.
Source: ClinicalTrials. gov: https://clinicaltrials.gov/ct2/show/study/NCT02951182