Immune Pharmaceuticals has initiated the screening of patients for a phase II proof-of-concept clinical trial exploring the safety and efficacy of bertilimumab in the treatment of ulcerative colitis (UC).
Professor Eran Goldin, chairman of the Institute for Digestive Diseases at Shaare Zedek Medical Center, part of the Hebrew University School of Medicine in Jerusalem, Israel, is the Principal Investigator of the trial, which will include over 10 clinical sites.
The Bertilimumab phase II clinical trial is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult patients with active moderate to severe UC. Eligible patients will be randomly assigned in a 2:1 ratio to one of two treatment groups, bertilimumab 10mg/kg or matching placebo, respectively.
The study will consist of three periods: a screening period of up to two weeks, a four-week double-blind treatment period (three IV infusions over 30 minutes, at two-week intervals), and a safety and efficacy follow-up period of approximately nine weeks. Patient selection is based on elevated tissue eotaxin-1, a biomarker that has been shown to be associated with severity of disease in bullous pemphigoid, ulcerative colitis, Crohn's disease, severe asthma and other conditions.
Bertilimumab is a recombinant human IgG4 monoclonal antibody that neutralizes human eotaxin-1 (eotaxin).