Allergan announced the initiation of two global clinical research programs for brazikumab, an investigational drug being studied for inflammatory bowel disease (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.
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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, which can result in irreversible gastrointestinal (GI) damage and potential surgery.
"Due to the complex nature and multifactorial causes of IBD, it can be challenging to predict which patients need and will respond to early advanced treatments," said Bruce E. Sands, MD, MS, Dr. Burrill B. Crohn Professor of Medicine at Mount Sinai Hospital in New York. "If we are able to identify whether certain biomarkers can predict a response to treatment, we may be able to select the most appropriate therapy for patients earlier."
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.
"The personalized study design of the INTREPID and EXPEDITION research programs reflect Allergan's commitment to finding new approaches in how we address the needs of patients with our medicines," said David Nicholson, Chief R&D Officer, Allergan. "These programs are part of our growing focus in gastroenterology, which will become even more significant for Allergan in the coming years."