Allergan announced the initiation of two global clinical research programs for brazikumab, an investigational drug being studied for inflammatory bowel disease. INTREPID (Crohn’s disease) and EXPEDITION (ulcerative colitis), will evaluate the safety and efficacy of brazikumab and will investigate the role of biomarkers in determining a predictive response of brazikumab in patients with IBD. They are the first active comparator studies of an IL-23 inhibitor therapy in IBD to evaluate biomarkers as potential predictors of treatment response and the first randomized comparison of an IL-23 inhibitor versus HUMIRA (adalimumab) in Crohn’s disease and ENTYVIO (vedolizumab) in ulcerative colitis. Allergan is initiating the INTREPID and EXPEDITION programs following a Phase 2 clinical trial that showed higher anti-inflammatory response and remission rates with brazikumab in patients with Crohn’s disease who had higher levels of a key IBD biomarker compared to those who had lower levels.
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