OREANDA-NEWS. Galapagos NV reports that Dr Severine Vermeire, principal investigator of the FITZROY Phase 2 study with investigational agent filgotinib in Crohn's disease, will present endoscopic and other key findings from the study in an oral session during United European Gastroenterology Week (UEG Week) in Vienna, Oct. 15 - 19, 2016.


The FITZROY Phase 2 study randomized 174 patients with Crohn's disease. Across the study, the average baseline CDAI score was 293, with average baseline SES-CD score of 14.6.

Variable/unit/population placebo n=44 filgotinib n=128 p-value
Clinical remission (CDAI<150), %, ITT-NRI 23 47 0.0077
SES-CD improvement by at least 50%, %, ITT-LOCF 13.6 25 NS
Overall total histopathology score, mean change from baseline, ITT-LOCF -0.6 -3.5 0.0359


"The endoscopic improvement and the histopathological benefit are additional strong and relevant indicators contributing to the potential of filgotinib as an oral treatment for Crohn's patients," said Dr Severine Vermeire, principal investigator of the FITZROY study. 

Overall, filgotinib was safe and well tolerated. Similar incidences in early discontinuations, SAEs and AEs including infections were observed, with the majority of the SAEs related to worsening of CD.  An increase in mean hemoglobin concentration was observed, without difference between filgotinib and placebo. No clinically significant changes from baseline in mean neutrophil counts or liver function tests were observed. Filgotinib showed a favorable lipid profile with an increase in HDL and no change in LDL, resulting in an improved atherogenic index.

"This is the first known double-blind, placebo-controlled study in Crohn's disease with endoscopic central reading as an inclusion criterion and as efficacy endpoint," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "Galapagos chose a 50% improvement in SES-CD scores as the appropriate hurdle for a potential new therapy option in Crohn's disease, and we are very pleased that endoscopic improvement was in line with observed clinical remission and response rates, CRP improvements, and patient reported outcomes."

Dr Vermeire will speak at UEG Week on 17 October 2016, at 16.20 CET, in the session entitled "Future drugs in IBD," abstract OP105, entitled: "Filgotinib, a selective JAK1 inhibitor, induces clinical remission in patients with moderate-to-severe Crohn's disease: final analysis of the Phase 2 FITZROY study."

Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib for inflammatory indications. Gilead initiated the FINCH Phase 3 program in rheumatoid arthritis in August 2016 and expects to initiate a Phase 3 study in Crohn's disease and a Phase 2/3 study in ulcerative colitis in Q4 2016.