Allergan is evaluating the use of biomarkers for the prediction of response to its IL-23 candidate brazikumab in patients with inflammatory bowel disease (IBD).

Inflammatory bowel disease (IBD) is a general term for diseases that involve chronic inflammation of the digestive tract, including ulcerative colitis (ulcers in the innermost lining of the large intestine [colon] and rectum) and Crohn’s disease (inflammation of the digestive tract lining). People with IBD suffer from severe diarrhea, abdominal pain, fatigue and weight loss. The disease can be debilitating and lead to some severe complications. 

Current treatments do not cure the disease for the vast majority of patients. In many cases, the disease progresses rapidly at early stages, leading to permanent damage to the gastrointestinal (GI) tract. Predicting which patients need and are likely to respond to treatment can be difficult, according to Bruce E. Sands, M.D., M.S., Dr. Burrill B. Crohn Professor of Medicine at Mount Sinai Hospital in New York. 

Allergan is hoping that the biomarkers may be useful for predicting the response to treatment of IBD patients with its candidate IL-23 inhibitor therapy brazikumab. The company has initiated two clinical trials for brazikumab in Crohn’s disease (INTREPID) and ulcerative colitis (EXPEDITION) to evaluate its safety and efficacy and to investigate the role of biomarkers in determining a predictive response of brazikumab in patients with IBD.

These two trials 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. They come after successful completion of a phase 2 study showing a 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 with those who had lower levels.