Allergan Launches Study Approach For Clinical Research Programs In IBD

(RTTNews) - Allergan plc (AGN) announced the initiation of two global clinical research programs for brazikumab, an investigational drug being studied for inflammatory bowel disease or IBD.

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.

Despite advancements in IBD treatments, up to 80 percent of patients will never achieve full disease remission.i In fact, many patients face rapid disease progression early in their treatment course due to ineffective or delayed therapies,ii which can result in irreversible gastrointestinal (GI) damage and potential surgery.

Allergan said it 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.