Vertex reports Phase II CF combo data

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) shed $5.21 to $125.79 on Monday after reporting the first 12-week data for VX-661 plus Kalydeco ivacaftor to treat cystic fibrosis in patients with two copies of the delta F508 CF transmembrane conductance regulator ( CFTR) mutation.

In the 39-patient Phase II study, patients who received 100 mg VX-661 once daily plus 150 mg Kalydeco twice daily showed an improvement over baseline in absolute percent predicted forced expiratory volume in one second (ppFEV1) of 4.4% at four weeks (p=0.009) and 3% over 12 weeks of treatment (p=0.026). The placebo arm experienced a 0.4% decline at four weeks (p=0.827) and 1% improvement over 12 weeks (p=0.451). Vertex said the four-week data are in line with the absolute improvement seen in a previous Phase II study of the combination (see BioCentury Extra, April 13, 2013). ...