ARTICLE | Clinical News

Galapagos reports Phase II data for GLPG2222 in CF

January 19, 2018 7:15 PM UTC

Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) reported top-line data from the Phase II FLAMINGO trial in 59 cystic fibrosis patients who were homozygous for the delta F508 cystic fibrosis transmembrane conductance regulator (CFTR) mutation showing that four dose levels of once-daily oral GLPG2222 for four weeks were well tolerated and dose-dependently reduced sweat chloride levels. Specifically, GLPG2222 reduced sweat chloride levels by up to 18.3 mmol/L from baseline to day 29 vs. a reduction of 2.5 mmol/L for placebo.

Patients in the trial had not received prior treatment with Orkambi ivacaftor/lumacaftor or tezacaftor (VX-661)/Kalydeco ivacaftor from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) for four weeks prior to dosing of GLPG2222. The double-blind, international trial evaluated safety as its primary endpoint. Secondary endpoints include the change from baseline up to day 29 in sweat chloride levels, forced expiratory volume in 1 second (FEV1) and pharmacokinetics...