Vertex Pharmaceuticals (MA) Release: Addition Of VX-661 To KALYDECO® (Ivacaftor) Improves Lung Function In People With CF Who Are Heterozygous For The F508del And G551D Mutations In 28-Day Phase 2 Proof-Of-Concept Study
Published: May 02, 2014
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that treatment with the combination of VX-661 and KALYDECO® (ivacaftor) in a 28-day Phase 2 study showed statistically significant improvements in lung function (FEV1) in people with both the F508del mutation and G551D mutation who were already taking KALYDECO. VX-661 was added to patients’ ongoing KALYDECO treatment for four weeks to evaluate the safety of the combination regimen as well as the effect on lung function, sweat chloride and other measures. In addition to improvements in FEV1, the addition of VX-661 also resulted in decreases in sweat chloride through the 28-day treatment period. Treatment with a combination of KALYDECO and VX-661 for 28 days resulted in a mean within-group absolute improvement in lung function of 4.6 percentage points (p=0.012), a mean within-group relative improvement in lung function of 7.3% (p=0.012) and a mean reduction in sweat chloride of -7.02 mmol/L (p=0.053) through the end of treatment. Following the 28-day treatment period, lung function and sweat chloride levels returned toward baseline. VX-661 was generally well-tolerated when dosed in combination with KALYDECO, and all 18 patients completed the 28-day treatment period.
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