Israel-based Immune Pharmaceuticals has commenced a double-blind, parallel group, randomised and placebo-controlled Phase II study of bertilimumab for the treatment of moderate-to-severe ulcerative colitis.
Human immunoglobulin monoclonal antibody, bertilimumab ( iCo-008 or CAT-213), targets eotaxin-1, a member of the chemokine family of proteins, which regulates eosinophilic inflammation.
The study will enrol 90 patients to evaluate the safety, clinical efficacy and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis.
In the study, 60 patients will receive bertilimumab 7mg/kg and 30 will be treated with placebo every two weeks at days 0, 14 and 28.
The patients, who will be followed up to day 90, will also be evaluated for clinical response after six weeks to determine the decrease, if any, in the full Mayo Clinic ulcerative colitis score.
Clinical remission, defined as symptom-free fecal calprotectin, a recognised marker of gastro-intestinal inflammation, histopathology improvement and degree of mucosal injury are the secondary and exploratory endpoints of the study.
The company expects completion of patient enrolment and clinical results in 2014.
The company also announced that bertilimumab will be the lead clinical stage development drug for the company, following completion of a proposed merger with EpiCept in the second quarter of 2013.