Galapagos NV has announced that the last patient has been randomized in the FITZROY Phase 2 clinical study. The study evaluates the efficacy and safety of filgotinib, a selective JAK 1 inhibitor, during 20 weeks of treatment in 175 patients with Crohn's disease.
Galapagos is eligible to receive $50 M fee from AbbVie if AbbVie elects to in-license filgotinib after receipt of the full RA DARWIN 1 and 2 data and elects to move forward with filgotinib in Crohn's disease.
Filgotinib is the first selective JAK1 inhibitor in development for Crohn's disease. The innovative design of the Phase 2 study with filgotinib evaluates induction of disease remission and explores early maintenance of its beneficial effects, potentially enabling a rapid entry into Phase 3 studies. Galapagos funded and conducted the Phase 2 study, recruiting patients with active Crohn's disease in 66 clinical centers in 9 countries throughout Western and Eastern Europe.
Galapagos expects to announce topline primary endpoint results following 10 weeks of treatment in December 2015, with 20 weeks results expected in Q1 2016. Full details of the study design can be found on www.clinicaltrials.gov.
The Phase 2 study in Crohn's disease is being performed in parallel with the DARWIN Phase 2B program for filgotinib in rheumatoid arthritis (RA). Galapagos expects to report final 24-week data from the second DARWIN study, evaluating filgotinib in a monotherapy setting, in August 2015. AbbVie has the exclusive right to license filgotinib upon its receipt of the final data package from the Phase 2B RA studies.
In the event that AbbVie in-licenses filgotinib following receipt of the full data package from the DARWIN 1 and DARWIN 2 Phase 2B studies in RA, Galapagos will also be eligible to receive an additional $50 million payment if AbbVie elects to move forward with filgotinib in Crohn's disease after receipt of the complete data set from the Crohn's study.