Immune Pharmaceuticals Ltd., a privately-held Israeli company, and EpiCept Corp. (EPCT.PK) Thursday announced that Immune is initiating a Phase II double-blind placebo controlled study with its lead drug bertilimumab in patients with moderate-to-severe ulcerative colitis.
Bertilimumab is a first-in-class fully human monoclonal antibody targeting eotaxin-1, a chemokine small protein regulating eosinophilic inflammation.
The clinical trial is a randomized, double-blind, placebo-controlled parallel group study. It will evaluate the safety, clinical efficacy, and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis.
Ninety patients are expected to be enrolled into the study, 60 of whom will be treated with bertilimumab 7mg/kg. Thirty people will be treated with placebo every two weeks, at days 0, 14, and 28.
These patients will be evaluated for clinical response after six weeks to determine the decrease if any in the Mayo Clinic Ulcerative Colitis Score.
Secondary and exploratory end points will include clinical remission defined as symptom free, fecal calprotectin, histopathology improvement and degree of mucosal injury. Completion of patient enrollment and clinical results are anticipated in 2014.
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