US-based Immune Pharmaceuticals has begun enrolling patients in a Phase II clinical trial of bertilimumab, a potential treatment for ulcerative colitis (UC).
Bertilimumab is a first-in-class, fully human monoclonal antibody.
A total of 42 patients with moderate to severe UC will be enrolled in the Phase II clinical trial.
During the trial, eligible patients will be randomly assigned to one of two treatment groups. One group will be prescribed 10mg/kg bertilimumab, and the other will given a matching placebo.
Patients will be given three IV infusions at two-week intervals. Bertilimumab will be evaluated for safety and efficacy, measured by a reduction in the Mayo Clinic Ulcerative Colitis Disease Index at week eight.
Immune CEO Dr Daniel Teper said: "We recently announced US IND acceptance by the FDA for bertilimumab in bullous pemphigoid, and today, with our first patient enrolment in ulcerative colitis, this represents an important development for our lead product, bertilimumab.
"We intend to include leading academic medical centres globally, to support the timely completion of our two Phase II clinical trials."
The Phase II trial’s secondary end points include assessment of mucosal injury and clinical remission.
The company noted that patients will be selected based on Mayo score and high levels of tissue eotaxin-1, as well as other standardised clinical criteria.
Robarts Research Institute CEO and University of Western Ontario professor Brian Feagan said: "We expect this trial to be an important proof of concept study in moderate to severe UC patients with elevated eotaxin-1.
"In addition to the Mayo Clinic Score of Disease activity, we expect the quantitative measurement of mucosal injury by centrally read endoscopy will provide an objective initial assessment of bertilimumab efficacy."
In Phase I single-dose clinical trials, bertilimumab showed initial safety and tolerability, as well as dose-dependent biological activity.
Image: Histopathological image of the active stage of ulcerative colitis. Photo: courtesy of KGH.