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Vertex Pharmaceuticals Incorporated Message Board

  • thirdmeinvestor thirdmeinvestor Jun 15, 2013 10:50 PM Flag

    Summary slide of ECFS presentation for VX-809/770 Phase II

    Summary and Conclusions from Cohort 2 and 3

    1. Pulmonary function was improved with the combination of lumacaftor with ivacaftor

    2. F508del homozygotes: lumacaftor 600 mg once-­daily or 400 mg every 12 hours with ivacaftor 250 mg every 12 hours for 28 days led to statistically and clinically significant improvements in FEV1

    3. Lumacaftor in combination with ivacaftor was generally well tolerated, and the safety profile was similar to placebo

    4. A subset of patients experienced dyspnea, chest tightness, and/or a decline in FEV1 coincident with initiation of 600 mg once-­daily or 400mg every 12 hours lumacaftor monotherapy

    5. These episodes were generally mild to moderate and transient and were not noted during combination therapy

    6. Based on these findings, two Phase 3 confirmatory studies, TRAFFIC and TRANSPORT, have been initiated to evaluate the effects of lumacaftor in combination with ivacaftor in patients homozygous for F508del

    7. These 24-­Week Phase 3 studies include both lumacaftor 600mg once daily and 400mg q12h in combination with 250mg ivacaftor.

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