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Apr 22, 2013
 |  BC Week In Review  |  Clinical News  |  Clinical Results

VX-661: Phase II data

Vertex reported data from a double-blind, placebo-controlled, international Phase II trial evaluating once-daily 10, 30, 100 and 150 mg doses of VX-661 for 28 days as monotherapy and in combination with twice-daily 150 mg Kalydeco ivacaftor ( VX-770) in 128 CF patients homozygous for the delta F508 CFTR mutation. All VX-661 monotherapy and combination arms met the primary endpoint of reducing mean absolute sweat chloride levels from baseline to day 28 vs. placebo. Vertex did not disclose detailed data on the primary endpoint, but said the changes in sweat chloride levels "were generally modest and were variable across the dose groups."

The 2 highest doses of VX-661 plus Kalydeco also met the secondary endpoint of improving mean relative percent predicted FEV1 from baseline to day 28 vs. placebo. Specifically, once-daily 100 mg VX-661 plus Kalydeco improved mean relative percent predicted FEV1 by 9% (p=0.01) and...

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