Immune Pharmaceuticals has started screening patients in its Phase II proof of concept clinical trial exploring the safety and efficacy of bertilimumab to treat ulcerative colitis (UC), a chronic, inflammatory auto-immune disorder.
This disorder is limited to the large bowel (colon and rectum) and only affects the inner lining of the colon.
Diarrhea is the main symptom of UC and is generally bloody and may be associated with abdominal pain.
Immune chairman and CEO Dr Daniel Teper said: "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."
The randomised, double blind, placebo-controlled, parallel group multi-centre trial will be carried out at more than ten clinical sites in adult patients with active moderate to severe UC.
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Shaare Zedek Medical Center chairman of the Institute for Digestive Diseases professor Eran Goldin is the principal investigator of the trial.
In the bertilimumab Phase II trial 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 trial will include three periods: a screening period of up to two weeks, a four-week double-blind treatment period which includes three IV infusions over 30 minutes, at two-week intervals, and a safety and efficacy follow-up period of about nine weeks.
Patient selection in the trial is based on elevated tissue eotaxin-1, a biomarker that has been shown to be associated with severity of disease in Bullous Pemphigoid, UC, Crohn’s disease, severe asthma and other conditions.
Image: H&E stain of a colonic biopsy showing a crypt abscess, a classic finding in ulcerative colitis. Photo: courtesy of KGH.