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Phase 2 Trial of Bertilimumab in UC Initiated
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Enrollment has begun in a phase 2 clinical trial evaluating the safety and efficacy of bertilimumab for ulcerative colitis, the manufacturer announced.
Bertilimumab (Immune Pharmaceuticals) is a first-in-its-class, fully human monoclonal antibody, according to a press release.
“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,” Daniel Teper, MD, CEO of Immune Pharmaceuticals, said in the press release. “We intend to include leading academic medical centers globally, to support the timely completion of our two phase 2 clinical trials.”
This phase 2, double-blind, placebo-controlled, randomized clinical trial is expected to enroll 42 patients with moderate-to-severe ulcerative colitis who will be randomly assigned to receive 10 mg/kg bertilimumab or placebo, according to the press release. They will receive three IV infusions over 30 minutes every 2 weeks, and the primary endpoints will be safety and efficacy as measured by week 8 reductions in Mayo Clinic Ulcerative Colitis Disease Index Scores. Secondary endpoints will be mucosal injury and clinical remission, and patient selection will be based on Mayo score, tissue eotaxin-1 levels and other clinical factors.
Brian Feagan
“We expect this trial to be an important proof of concept study in moderate to severe UC patients with elevated eotaxin-1,” Brian Feagan, MD, professor of medicine at University of Western Ontario, and CEO of Robarts Research Institute, said in the press release. “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.”
Previous phase 1 single-dose clinical trials showed safety, tolerability and dose-dependent biological activity of bertilimumab, according to the press release. One study demonstrated tissue eotaxin-1 levels and disease activity index in UC patients was positively correlated (P = .006; r = 0.318); those researchers concluded that eotaxin-1 is implicated in the etiology of UC and that measuring it may be useful in patient selection for bertilimumab treatment.
“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,” Eran Goldin, MD, chairman of the Digestive Disease Institute and head of gastroenterology at Shaare Zedek Medical Center in Jerusalem, said in the press release. “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 [UC].”
Indications for which bertilimumab is also being considered for development include atopic dermatitis, Crohn’s disease, severe asthma and NASH, according to the press release.
Disclosures: Teper reports he is an employee of Immune Pharmaceuticals. Healio Gastroenterology was unable to confirm Feagan’s and Goldin’s relevant financial disclosures at the time of publication.