24 May 2016, 22.00 CET
Successful completion of End-of-Phase 2 FDA and EMA consultations in rheumatoid arthritis (RA)
? FINCH Phase 3 studies to start in Q3’16
? Three registration studies addressing a broad population of RA patients
? 100 mg and 200 mg once daily dosing in males and females world-wide
Mechelen, Belgium; 24 May 2016 – Galapagos NV (Euronext & NASDAQ: GLPG) reports the successful completion of the discussions with the regulatory authorities in the US and Europe and discloses the doses for the FINCH global Phase 3 program with filgotinib in RA. The FINCH program will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily, globally addressing a broad RA patient population, with dosing expected to begin in Q3’16. The FINCH Phase 3 program will also contain a dedicated male patient testicular safety study.
“We are pleased with the outcome of the End-of-Phase 2 discussions with FDA and EMA, as the FINCH program, led by our collaboration partner Gilead, will enable a comprehensive Phase 3 evaluation of simultaneously 100 mg and 200 mg filgotinib in both males and females in major RA patient populations world-wide,” said Piet Wigerinck, Chief Scientific Officer at Galapagos. “Gilead and Galapagos have worked diligently to complete the transition, such that Gilead is now poised to initiate multiple studies with filgotinib in inflammatory diseases.”
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib for inflammatory indications. In addition to the FINCH program in RA, Gilead expects to initiate a Phase 3 study with filgotinib in Crohn’s disease and a Phase 2/3 study in ulcerative colitis in Q3 ’16. Interactions with the regulatory authorities in these indications are still pending and will be reported on later.