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Galapagos NV

Galapagos NV

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Publicatie datum 21 apr 2016 - 22:00
Statutaire naam Galapagos NV
Titel Galapagos reports additional data with filgotinib from the Phase 2 FITZROY study
Bericht Filgotinib: an investigational JAK-inhibitor shows efficacy in Crohn's disease Clinical responses continued from week 10 to week 20 Safety profile similar to that previously observed Phase 3 program in Crohn's disease to be initiated in 2016 Mechelen, Belgium; 21 April 2016 - Galapagos NV (Euronext & NASDAQ: GLPG) reported 20-week results from its FITZROY study with the investigational, selective JAK1 inhibitor filgotinib in Crohn's disease. 174 patients with moderately to severely active Crohn's disease were enrolled in FITZROY, a double-blind, placebo-controlled Phase 2 study. Patients recruited were either anti-TNF naïve or anti-TNF failures. The study comprised two parts each of 10 weeks duration: the first part - reported in December 2015 - investigated the safety and efficacy of filgotinib 200 mg once daily versus placebo. The FITZROY study achieved the primary endpoint of clinical remission at 10 weeks: the percentage of patients achieving a Crohn's Disease Activity Index (CDAI) score lower than 150 was significantly higher in patients treated with filgotinib versus patients receiving placebo. Improvement in histopathology and endoscopy assessments were observed at Week 10. Further evaluation is ongoing.