Galapagos has completed discussions with U.S. and European regulatory authorities to begin the DIVERSITY Phase 3 clinical trial (NCT02914561) in patients with Crohn’s disease and the SELECTION Phase 2b/3 study (NCT02914522) in ulcerative colitis with filgotinib.
Filgotinib is a selective inhibitor of the JAK1 (Janus kinase 1), an enzyme involved in the signaling pathways of several pro-inflammatory cytokines, ultimately leading to inflammation. It is the first JAK inhibitor to show efficacy in Crohn’s disease, a disease that still has few treatment options.
Both trials will assess the efficacy and safety of filgotinib (100 mg and 200 mg once daily) versus placebo in patients with moderate-to-severe active Crohn’s disease, either anti-TNF naive or anti-TNF failures. Neither trial is recruiting patients yet, but the company expects to administer the first doses to patients later this year.
A population of 1.300 patients for each study will be recruited from the U.S., Europe, Latin America, Canada, and Asia/Pacific. The SELECTION trial in patients with ulcerative colitis will involve a futility analysis, which will serve as the Phase 2b part of the study.
In the U.S., men will be treated with 200 mg of filgotinib if they failed at least one anti-TNF, and vedolizumab. The Phase 3 program of filgotinib also will incorporate a testicular safety analysis.
“The outcome of the discussions with U.S. and national European regulatory authorities enables our collaboration partner Gilead to further evaluate filgotinib in IBD,” Piet Wigerinck, PhD, chief scientific officer at Galapagos, said in a press release.”The improvements in clinical signs, quality of life and endoscopy in Crohn’s patients reported in the FITZROY Phase 2 study support this next step,” he said.
Galapagos recently reported it will present endoscopic improvements and other key findings from FITZROY, a Phase 2 study of filgotinib in 174 patients with Crohn’s disease at United European Gastroenterology Week (UEG Week).
Galapagos and Gilead Sciences started a global partnership for the development and commercialization of filgotinib for inflammatory diseases. In August, Gilead launched the FINCH Phase 3 program for filgotinib for the treatment of rheumatoid arthritis.
Crohn’s disease is a type of inflammatory bowel disease (IBD) that may affect any part of the gastrointestinal tract, from mouth to anus. Signs and symptoms often include abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever and weight loss. Crohn’s disease is caused by a combination of environmental, immune and bacterial factors in genetically susceptible individuals, whose gastrointestinal tracts are attacked by their immune system.
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