Immune Pharmaceuticals Initiates Phase 2 Clinical Trial with Bertilimumab for Ulcerative Colitis Treatment

Immune Pharmaceuticals Initiates Phase 2 Clinical Trial with Bertilimumab for Ulcerative Colitis Treatment
Immune Pharmaceuticals, Inc. recently announced the enrollment of the first patient in its Phase 2 clinical trial to assess the safety and efficacy of the first-in-class, entirely human monoclonal antibody bertilimumab for the treatment of ulcerative colitis (UC). "We recently announced U.S. IND [Investigational New Drug] acceptance by the FDA for bertilimumab in bullous pemphigoid, and today, with our first patient enrollment in ulcerative colitis, this represents an important development for our lead product, bertilimumab. We intend to include leading academic medical centers globally, to support the timely completion of our two Phase 2 clinical trials," explained Dr. Daniel Teper, Immune Pharmaceuticals’ CEO, in a press release. This Phase 2 trial will be a randomized, double-blind, placebo-controlled study, designed to include 42 patients with moderate to severe UC. Patients will be chosen based on Mayo Clinic Ulcerative Colitis Disease Index results, high levels of the tissue eotaxin-1, and other clinical criteria. Eotaxin-1 is a protein encoded by the CCL11 gene, which is known to play a role in the recruitment and function of eosinophils (a type of white blood cell). Patients with active UC are known to have increased serum levels of eotaxin-1. UC patients eligible for the trial will be distributed at random into two categories in a ratio of two to one: one group will be given 10mg/kg of bertilimumab and the other will receive a placebo, respectively. For 30 minutes every two weeks, patients will receiv
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