Immune Pharmaceuticals, Inc. recently announced the enrollment of the first patient in its Phase 2 clinical trial to assess the safety and efficacy of the first-in-class, entirely human monoclonal antibody bertilimumab for the treatment of ulcerative colitis (UC).
“We recently announced U.S. IND [Investigational New Drug] 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,” explained Dr. Daniel Teper, Immune Pharmaceuticals’ CEO, in a press release.
This Phase 2 trial will be a randomized, double-blind, placebo-controlled study, designed to include 42 patients with moderate to severe UC. Patients will be chosen based on Mayo Clinic Ulcerative Colitis Disease Index results, high levels of the tissue eotaxin-1, and other clinical criteria. Eotaxin-1 is a protein encoded by the CCL11 gene, which is known to play a role in the recruitment and function of eosinophils (a type of white blood cell). Patients with active UC are known to have increased serum levels of eotaxin-1.
UC patients eligible for the trial will be distributed at random into two categories in a ratio of two to one: one group will be given 10mg/kg of bertilimumab and the other will receive a placebo, respectively. For 30 minutes every two weeks, patients will receive three intravenous infusions. At week 8 after the start of the treatment, its safety and efficacy will be evaluated through a reduction in the Mayo Clinic Ulcerative Colitis Disease Index. The trial will also assess mucosal injury and clinical remission in the selected patient cohort. Investigators expect this trial to be the necessary proof of concept research in UC patients with higher levels of eotaxin-1.
A previous research study, published in December 2013 in Plos One, titled “Closing the Gap: Increases in Life Expectancy among Treated HIV-Positive Individuals in the United States and Canada”, already suggested a positive correlation between tissue eotaxin-1 levels and disease activity in UC patients. The authors concluded that eotaxin-1 measurement may be an important indicator to identify patients who could benefit from a bertilimumab treatment.
“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,” explained Brian Feagan, MD, Professor of Medicine at the University of Western Ontario and CEO of Robarts Research Institute.
“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,” said Eran Goldin, MD, Chairman of Digestive Disease Institute and Head of Gastroenterology at Shaare Zedek Medical Center in Jerusalem, Israel.
Immune Pharmaceuticals is developing personalized strategies in the development of therapeutics to improve the quality of life of inflammatory diseases and cancer patients. Bertilimumab is the company’s leading product candidate now in clinical trials for moderate to severe ulcerative colitis and bullous pemphigoid, an auto-immune dermatological disease. Other indications include atopic dermatitis, asthma, Crohn’s disease, and inflammatory liver disease.