Galapagos Reports Positive Phase 2 Trial Data of Crohn’s Disease Drug Filgotinib at ECCO Congress

Galapagos Reports Positive Phase 2 Trial Data of Crohn’s Disease Drug Filgotinib at ECCO Congress
Galapagos recently presented data from the FITZROY Phase 2 clinical trial of filgotinib for Crohn's disease at the 11th ECCO Congress in Amsterdam. Prof. Séverine Vermeire, lead investigator of the trial, presented the analysis of the 10-week treatment study. In the FITZROY trial, 174 patients were treated with either a placebo or  200 milligrams of filgotinib in a ratio 1 to 4. Belgium-based Galapagos, which reported these results in December 2015, demonstrated that the study met its primary endpoint  of clinical remission. Specifically, the results showed that a higher percentage of patients treated with filgotinib achieved a Crohn's Disease Activity Index (CDAI) score of less than 150, compared with patients treated with a placebo (48 percent vs. 23 percent). In addition, treatment with filgotinib showed improvement in quality of life (IBDQ) in TNF-naive and TNF-failure patients. In terms of safety profile, the rate of adverse events was similar between filgotinib and placebo-treated patients. The most common adverse events reported were infections and infestations (26 percent vs. 23 percent), gastrointestinal disorders (24 percent vs. 23 percent) and disorders of the nervous system (16 percent vs. 18 percent). Filgotinib is the first JAK inhibitor to show efficacy in Crohn’s disease, a disease that still has few treatment options. The FITZROY study confirms Galapagos' growing confidence in the safety of this novel drug, so the company is movin
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