DUBLIN /PRNewswire/ -- Allergan plc (NYSE: AGN) today 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.
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,iiwhich can result in irreversible gastrointestinal (GI) damage and potential surgery.iii
"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.iv
"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."
More about INTREPID and EXPEDITION
INTREPID is a patient-centric Phase 2b/3, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group, Crohn's disease program. In Stage 1 (Phase 2b), brazikumab will be compared to placebo and HUMIRA® (adalimumab) and in Stage 2 (Phase 3) brazikumab will be compared to HUMIRA® only. Approximately 450 patients will be enrolled in Stage 1 and 690 patients in Stage 2. To the benefit of study participants, all will have post-trial access to study treatments.
EXPEDITION is starting with a Phase 2, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group, study of patients with ulcerative colitis. The safety and efficacy of brazikumab will be compared to placebo or ENTYVIO® (vedolizumab). Approximately 375 patients will be enrolled. Biomarker learnings from this study will be applied to the planned Phase 3 part of the program.
The primary endpoints of INTREPID include evaluations of endoscopic response and clinical remission based on loose stool frequency and abdominal pain scores.The primary endpoints of EXPEDITION include evaluations of endoscopic response and clinical remission based on loose stool frequency and rectal bleeding. In both programs, patients who previously received standard biologic therapy (biologic-intolerant or -refractory) and those who were never treated with biologic therapy (biologic-naïve) will be enrolled. Patients who received conventional therapies, such as corticosteroids or immunomodulators, will also be included. Where available, participants will have access to study treatments after the programs are completed until brazikumab is commercially available or Allergan ceases development. INTREPID expects to begin enrolling patients in December 2018. EXPEDITION is actively enrolling patients. Learn more at AllerganIBD.com.
More about IBD
Inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, causes chronic inflammation in the GI tract. Crohn's disease can affect any part of the GI tract, from the mouth to the anus. Ulcerative colitis, however, only affects the large intestine (colon) and the rectum.
The exact causes of IBD are not fully understood.ii It is a complex disease involving multiple genetic, immune system and environmental factors that can lead to poor quality of life and high economic and personal costs.ii
More about Allergan Gastroenterology
In addition to INTREPID and EXPEDITION, Allergan is exploring investigational products for diabetic gastroparesis (DG) and nonalcoholic steatohepatitis (NASH) through its PLEDGE and AURORA research programs. PLEDGE is studying relamorelin, an investigational drug being evaluated for DG and AURORA is evaluating Cenicriviroc (CVC), an investigational drug for liver fibrosis in adults with NASH. Both relamorelin and CVC have been granted Fast Track status by the U.S. Food and Drug Administration (FDA).
Learn more at AllerganGastroenterology.com.
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; uncertainty associated with financial projections, debt reduction, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2017 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2018. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
i Feldman, P. A., Wolfson, D., & Barkin, J. S. (2007). Medical Management of Crohn's Disease. Clinics in Colon and Rectal Surgery, 20(4), 269–281. http://doi.org/10.1055/s-2007-991026
ii Facts about Inflammatory Bowel Diseases. (2011, May 1) CCFA. http://www.crohnscolitisfoundation.org/resources/facts-about-inflammatory.html. Retrieved on Sept. 18, 2018.
iii Lichtenstein, Gary R. et al. (2018). "ACG Clinical Guideline: Management of Chron's Disease in Adults." The American Journal of Gastroenterology, 113, 481–517
iv Sands, Bruce E. et al. (2017). Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients with Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology, Volume 153, Issue 1, 77 - 86.e6
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