Galapagos NV has reported that the successful completion of discussions with the regulatory authorities in the US and Europe to initiate the DIVERSITY Phase 3 study in Crohn’s disease and the SELECTION Phase 2b/3 study in ulcerative colitis with filgotinib. Both studies will investigate efficacy and safety of 100 mg and 200 mg filgotinib once daily compared to placebo in patients with moderately to severely active disease including those with prior antibody therapy failure. First dosing is expected in Q4’16.
Both studies will recruit approximately 1,300 patients each from the US, Europe, Latin America, Canada, and Asia/Pacific. The SELECTION Phase 2b/3 study in ulcerative colitis will include a futility analysis, serving as the Phase 2b part of this integrated Phase 2b/3 study. Men and women in both the SELECTION and DIVERSITY studies will be randomized to receive placebo, 100 mg or 200 mg filgotinib.
In the US, males may receive 200 mg if they failed at least one antiTNFand vedolizumab1.The filgotinib Phase 3 program will also contain a dedicated male patient testicular safety study. “The outcome of the discussions with US and national European regulatory authorities enables our collaboration partner Gilead to further evaluate filgotinib in IBD,” said Dr Piet Wigerinck, Chief Scientific Officer at Galapagos.
“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.” Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. Gilead initiated the FINCH Phase 3 program in rheumatoid arthritis in August 2016. Filgotinib is an investigational therapy and its efficacy and safety have not been established.