Gilead and Galapagos N.V announced positive topline results from the phase 2b/3 SELECTION trial evaluating the efficacy and safety of filgotinib versus placebo in biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC). Filgotinib 200 mg achieved all primary endpoints in the study. Detailed results from the SELECTION trial will be submitted for presentation at a future scientific conference.
The randomized, double-blind, placebo-controlled trial enrolled1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC). The trial comprised 2 Induction Trials and a Maintenance Trial. The Cohort A Induction Trial enrolled biologic-naive patients, and the Cohort B Induction Trial enrolled biologic-experienced patients. Across both induction studies, patients with moderately to severely active UC were randomized to receive filgotinib 200 mg, filgotinib 100 mg or placebo in a 2:2:1 ratio. Patients with clinical remission or response at Week 10 of induction were subsequently re-randomized to the induction dose of filgotinib or placebo in a 2:1 ratio and treated through Week 58.
Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo. Filgotinib 100 mg did not achieve statistically significant clinical remission at Week 10. Rates of serious infections, herpes zoster, venous thrombosis, pulmonary embolism and gastrointestinal perforation were low and comparable across treatment groups in both the induction and maintenance phases of the study.
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications in 2015.
Filgotinib is an orally bioavailable inhibitor of the tyrosine kinase Janus kinase 1 (JAK1), with potential anti-inflammatory and immunomodulating activities.Source: Gilead