Galapagos Starts Phase 3 Trial of Filgotinib for Crohn’s Disease

Galapagos Starts Phase 3 Trial of Filgotinib for Crohn’s Disease
Galapagos, a clinical-stage biotech specializing in small molecule medicines, has dosed its first patient in its DIVERSITY (NCT02914561) Phase 3 clinical trial of filgotinib in Crohn’s disease. The trial is currently recruiting participants. The initiation of the trial triggered a $50 million milestone payment from Gilead, the co-developer of filgotinib, a selective inhibitor of the JAK1 (Janus kinase 1), an enzyme involved in the signaling pathways of several pro-inflammatory cytokines, which ultimately lead to inflammation. Filgotinib is the first JAK inhibitor to show effectiveness in Crohn's, but it is still an investigational drug. The Phase 3 trial’s primary objectives are to evaluate the drug’s effectiveness and safety in the induction and maintenance of remission in subjects with moderate-to-severe Crohn's disease. The DIVERSITY study will investigate two doses of filgotinib (100 mg and 200 mg) once-daily compared to a placebo in 1,230 patients, including those with prior biological therapy failure. Participants who complete the study – or who do not meet protocol response or remission criteria at week 10 – will have the option to enter a separate long-term extension (LTE) study (NCT02914600). "With the FITZROY Phase 2 study, Galapagos demonstrated that filgotinib h
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