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).
Dr. Daniel Teper, chairman and chief executive officer, of Immune comments, "Bertilimumab is among the first biologic drugs for auto-immune diseases with a biomarker strategy. We look forward to the results of this phase II proof of concept clinical trial in ulcerative colitis as well as the previously initiated phase II clinical trial in Bullous Pemphigoid, an orphan auto-immune disease of the skin."
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 randomised, double blind, placebo-controlled, parallel group multi-centre 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 10 mg/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 neutralises human eotaxin-1 (eotaxin).
Ulcerative colitis is a chronic, inflammatory auto-immune disorder limited to the large bowel (colon and rectum) and only affects the inner lining of the colon. The main symptom is diarrhoea that is generally bloody and may be associated with abdominal pain. Loss of appetite and subsequent weight loss are common, as is fatigue. Severe bleeding may result in anemia. The symptoms of ulcerative colitis tend to come and go, with fairly long periods in between flare-ups in which patients may experience no distress at all.