Galapagos will present endoscopic improvements and other key findings from the FITZROY Phase 2 clinical trial of filgotinib in Crohn’s disease, during United European Gastroenterology Week (UEG Week), Oct. 15-19, in Vienna.
Lead investigator Dr. Séverine Vermeire will present the abstract titled “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” on Oct. 17.
The FITZROY trial (NCT02048618) assessed the effectiveness and safety of filgotinib (200 mg once daily) versus placebo in 174 patients with moderate to severe active Crohn’s disease and who were either anti-TNF naive (never treated before) or anti-TNF failures.
During UEG Week, Vermeire will show that treatment with filgotinib resulted in clinical remission and also resulted in improvements in endoscopic scores for Crohn’s disease. The improvement results were measured by the disease activity measurement tools CGAI and SES-CD, respectively.
“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 Vermeire in a press release.
During FITZROY, there were no new safety issues reported and filgotinib was well tolerated. While there were increases in average hemoglobin concentration, there were no differences between filgotinib and placebo-treated patients. Moreover, there were also no clinically meaningful changes across the study in liver function tests or in the average neutrophil counts. Treatment with filgotinib demonstrated a positive lipid profile with an increase in HDL and no modification in LDL, which resulted in improvements in the 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.”
Galapagos and Gilead Sciences are in partnership for the development and commercialization of filgotinib for inflammatory diseases. In August, Gilead started the FINCH Phase 3 program in rheumatoid arthritis (RA). The company plans to start a Phase 3 clinical trial in Crohn’s disease and a Phase 2/3 clinical trial in ulcerative colitis later this year.
For information about the abstract presentation and 2016 UEG Week check out www.ueg.eu/week/.