Gilead Sciences and Galapagos NV announced positive topline results from the phase 2b/3 SELECTION trial of filgotinib, an oral selective JAK1 inhibitor, for the treatment of moderately to severely active ulcerative colitis.

The multicenter, double-blind, placebo-controlled trial included 1348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis. The trial consisted of 2 induction studies and a maintenance study. In the induction study, patients were randomized 2:2:1 to receive filgotinib 200mg, 100mg, or placebo for 10 weeks. After 10 weeks, patients who achieved clinical remission or response were re-randomized 2:1 to receive either the induction dose of filgotinib or placebo for 48 weeks. 

The primary end points of the study were the proportion of patients achieving clinical remission (defined as an endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥1 point decrease in stool frequency from baseline to achieve a subscore of 0 or 1) at week 10 and maintaining clinical remission at week 58.

At week 10, 26.1% of biologic-naïve patients treated with filgotinib 200mg achieved clinical remission compared with 15.3% in the placebo arm (P =.0157). Among biologic-experienced patients, 11.5% of patients achieved clinical remission with filgotinib 200mg compared with 4.2% in the placebo arm (P =.0103). Treatment with filgotinib 100mg did not result in statistically significant clinical remission at week 10.

At week 58, both doses of filgotinib achieved the primary end point in the maintenance trial. Among biologic-naïve and biologic-experienced patients who received filgotinib 200mg, 37.2%  achieved clinical remission compared with 11.2% in the placebo arm (P <.0001). Among those who received the 100mg dose, 23.8% achieved clinical remission compared with 13.5% in the placebo arm (P =.042).

Full detailed results will be submitted for presentation at a future scientific conference. Additionally, the safety of filgotinib is being assessed in an ongoing SELECTION long-term extension trial in patients who completed the treatment up to week 58.

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“We are pleased to see that SELECTION results indicate that filgotinib can help ulcerative colitis patients, including those refractory to treatment, achieve and sustain remission for more than 1 year,” said Dr Walid Abi-Saab, Chief Medical Officer, Galapagos. “We believe that the results point to an efficacy and safety profile consistent with prior studies with filgotinib, and offer a meaningful contribution to the patient data with filgotinib from other inflammatory conditions.”

Filgotinib is currently being investigated in several clinical studies, including the FINCH phase 3 program in rheumatoid arthritis, the DIVERSITY phase 3 trial in Crohn disease, the phase 3 PENGUIN trials in psoriatic arthritis, and phase 2 studies in uveitis and in small bowel and fistulizing Crohn disease.

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