New Data Supports Clinical Rationale for Bertilimumab in Ulcerative Colitis





Immune Pharmaceuticals Inc. announced today that Tomer Adar, M.D. at the Digestive Diseases Institute, Shaare Zedek Medical Center, Hebrew University of Jerusalem, presented a poster on October 15, 2013 entitled Inhibition of Eotaxin-1 (CCL 11) Ameliorates DSS-Induced Colitis; A Novel Potential Therapeutic Approach for Inflammatory Bowel Disease, at the United European Gastroenterology Week being held in Berlin, Germany.
This study was performed to evaluate the effect of eotaxin-1 (CCL-11) inhibition on BALB/c mice with dextran sodium sulfate (DSS)-induced colitis. The mice were treated with an anti-eotaxin-1 monoclonal antibody or a control antibody. Inhibition of eotaxin-1 resulted in significant amelioration of DSS-induced colitis demonstrated by statistically significant reduction in both disease activity index and body weight loss compared to controls. These results indicate the importance of eotaxin-1 in regulating intestinal mucosal inflammation, and its potential as a future therapeutic target in inflammatory bowel disease (IBD).
Bertilimumab is a fully human monoclonal antibody with high specificity for human eotaxin-1. Bertilimumab was originally developed by Cambridge Antibody Technologies, now part of MedImmune, the Global Research and Development Arm of AstraZeneca. Immune has initiated a double blind placebo controlled Phase II international study, which compares bertilimumab with placebo in 105 patients with moderate to severe ulcerative colitis. Patients are selected based on elevated eotaxin-1 levels from colonic biopsy samples. Topline data from this trial is expected in early 2015.
Eran Goldin, M.D., Chairman of the Digestive Diseases Institute at Shaare Zedek Medical Center in Jerusalem, commented: "Eotaxin-1 is a biomarker of IBD and a potential target for therapeutic intervention. This new selective approach is promising for patients with moderate to severe ulcerative colitis. We look forward to the Phase II clinical data with bertilimumab."
Marc Rothenberg, M.D.,Ph.D., Director of the Division of Allergy and Immunology at Cincinnati Children''s Hospital Medical Center, one of the pioneer researchers on eotaxin, commented: "Eotaxin-1 is a key regulator of gastrointestinal eosinophils, and its neutralization by bertilimumab is an attractive approach to potentially treating IBD. Bertilimumab targets the innate (not adaptive) immune system by blocking an inflammatory ligand, similar to the action of anti-TNF therapies. The study by Professor Eran Goldin''s group adds further data substantiating a contributory role of eotaxin-1 and eosinophils in key processes involved in IBD."
About Immune Pharmaceuticals Inc.
Immune Pharmaceuticals Inc. applies a personalized approach to treatment, developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. The Company''s lead product candidate, bertilimumab, is entering Phase II clinical studies for moderate to severe ulcerative colitis and bullous pemphigoid, with additional studies planned for Crohn''s disease and severe asthma. The Company is evaluating the use of its NanomAb® platform, a second generation antibody drug conjugate technology, with chemotherapeutics in order to enhance their safety and efficacy profiles by delivering the medicines directly to cancer cells. The Company''s growing oncology pipeline also includes proprietary antibodies and, clinical-stage small molecules that have been shown activity in a variety of solid tumors.
Immune licensed worldwide rights for systemic indications of bertilimumab from iCo Therapeutics  in June 2011, while iCo retained rights to all ophthalmic indications. iCo originally licensed the exclusive world-wide rights to bertilimumab in 2006 from MedImmune, the Global Research and Development Arm of AstraZeneca.