Galapagos announced positive study data from the Phase 2 trial, FITZROY, evaluating filgotinib for the treatment of Crohn’s Disease. Detailed results were presented at Digestive Disease Week 2016 in San Diego, CA.

The FITZROY study was a randomized, Phase 2 trial evaluating filgotinib vs. placebo for 10 weeks in 174 patients with Crohn’s Disease. The primary endpoint was clinical remission, defined as the percentage of patients achieving a Crohn’s Disease Activity Index (CDAI) score <150. 

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Results of the trial were presented by Prof. Dr. Séverine Vermeire, the principal investigator of the FITZROY study. Data showed that a statistically significantly higher number of patients treated with filgotinib achieved clinical remission compared to placebo at 10 weeks, meeting the study’s primary endpoint (P=0.0067). Additionally, treatment with filgotinib also demonstrated statistically significant improvement in quality of life (IBDQ) vs. placebo (P=0.0045). Safety and tolerability profiles were comparable between the filgotinib and placebo arms. 

Filgotinib is a highly selective oral JAK1 inhibitor.

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