Immune Pharmaceuticals Inc. (NASDAQ: IMNP) ("Immune" or the "Company") announced today that the first patient has been enrolled into the Phase 2 clinical trial evaluating the safety and efficacy of its first in class fully human monoclonal antibody, bertilimumab in Ulcerative Colitis (UC).
"We recently announced U.S. IND acceptance by the FDA for bertilimumab in bullous pemphigoid, and today, with our first patient enrollment in ulcerative colitis, this represents an important development for our lead product, bertilimumab. We intend to include leading academic medical centers globally, to support the timely completion of our two Phase 2 clinical trials," said Dr. Daniel Teper, CEO of Immune.
This double blind placebo-controlled randomized Phase 2 clinical trial is planned to enroll 42 patients, with 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. Patients will receive three IV infusions over 30 minutes, at two-week intervals and will be evaluated for safety as well as efficacy measured by a reduction in the Mayo Clinic Ulcerative Colitis Disease Index at week 8.
Secondary end points include assessment of mucosal injury and clinical remission. Patients will be selected based on Mayo score and high levels of tissue eotaxin-1, as well as other standardized clinical criteria.
Brian Feagan, M.D., Professor of Medicine, University of Western Ontario, CEO of Robarts Research Institute stated, "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."
To date, in previously conducted Phase 1 single dose clinical trials, bertilimumab demonstrated initial safety and tolerability as well as dose dependent biological activity.
A Vanderbilt study, supported by a grant from the National Institute of Health (NIH), and published in PlosOne (PLoS One. 2013 Dec 18;8(12)) showed a positive correlation (p=0.006, r=0.318) between tissue eotaxin-1 levels and disease activity index in UC patients. The authors concluded that their data implicates eotaxin-1 in the etiology of UC, and that eotaxin-1 measurement may be useful to select patients for therapy with bertilimumab.
Eran Goldin, M.D., Chairman, Digestive Disease Institute and Head of Gastroenterology at Shaare Zedek Medical Center in Jerusalem, Israel, commented, "It is really exciting for me as a clinical researcher in Inflammatory Bowel Disease, that for the first time, a patient from Israel with active UC has received a new treatment, bertilimumab, within the frame of a Phase 2 clinical trial. Bertilimumab is a new and, I believe, promising biological medicine, targeting eotaxin-1 and is known to have potent anti-inflammatory effects in UC and other diseases. In research that we conducted at our institute, eotaxin-1 was shown to be elevated in over 50% of patients with moderate to severe UC or Crohn's disease. Additionally, we demonstrated in animal studies that neutralizing eotaxin-1 leads to a reduction in the symptoms of ulcerative colitis."
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