Therapy Areas: Inflammatory Diseases
Phase 2b/3 Trial Shows Efficacy of Filgotinib for the Induction and Maintenance of Remission in Moderately and Severely Active Ulcerative Colitis
13 October 2020 - - US-based biopharmaceutical company Gilead Sciences, Inc. (NASDAQ: GILD) and Belgium-based small molecule medicines developer Galapagos NV (Euronext and NASDAQ: GLPG) have presented late-breaking data demonstrating sustained efficacy and safety with filgotinib, an investigational, oral, once-daily, JAK1 preferential inhibitor, for the treatment of moderately to severely active ulcerative colitis, the companies said.

The data from the randomized, double-blind, placebo-controlled, Phase 2b/3 SELECTION trial showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 and maintained remission through Week 58.

In addition, significantly more patients achieved six-month corticosteroid-free remission.

UC is a longer-term condition characterized by inflammation of the mucosal lining of the colon and rectum.

An increasingly prevalent disease, UC has a significant impact on the quality of life of more than 2m people around the world.

Despite current treatments, many patients experience fecal urgency, incontinence, recurring bloody diarrhea and the need to empty their bowels frequently, often accompanied by abdominal pain, poor sleep and fatigue.

The SELECTION study included biologic-naïve patients, for whom prior conventional therapy had failed, as well as biologic-experienced patients a high proportion of whom had been non-responders to at least two different lines of prior biologics.

In total, 43 % of patients in the biologic-experienced cohort had failed treatment with both a TNF inhibitor and vedolizumab.

The study allowed the enrollment of patients who were taking steroids, and/or immunomodulators, including methotrexate, mercaptopurine or azathioprine, as they would in real-world clinical practice.

Overall, 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active UC were randomized and treated in the SELECTION study.

Among biologic-naïve patients treated with filgotinib 200 mg, a significantly higher proportion of patients achieved clinical remission at Week 10 compared with placebo (26.1% vs. 15.3%, p=0.0157).

Additionally, a significantly higher proportion of biologic-naïve patients treated with filgotinib 200 mg versus placebo achieved Mayo Clinic Score remission (24.5% vs. 12.4%, p=0.0053), endoscopic remission (12.2% vs. 3.6%, p=0.0047) and histologic remission (35.1% vs. 16.1%, p
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