Immune Pharmaceuticals Ltd. and EpiCept Corporation announced that Immune is initiating, following authorization from Israeli health authorities, a Phase II double-blind placebo controlled study with its lead drug, bertilimumab, in patients with moderate-to-severe ulcerative colitis. Bertilimumab is a first-in-class fully human monoclonal antibody targeting eotaxin-1, a chemokine small protein regulating eosinophilic inflammation.
The clinical trial is a randomized, double-blind, placebo-controlled parallel group study that will evaluate the safety, clinical efficacy, and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis. 90 patients are expected to be enrolled into the study, 60 of whom will be treated with bertilimumab 7mg/kg and 30 of whom will be treated with placebo every two weeks, at days 0, 14, and 28. These patients will be evaluated for clinical response after six weeks to determine the decrease if any in the full Mayo Clinic Ulcerative Colitis Score. Secondary and exploratory end points will include clinical remission defined as symptom free, fecal calprotectin, a recognized marker of gastro-intestinal inflammation, histopathology improvement and degree of mucosal injury. Patient follow-up will continue up to day 90. Patients will be enrolled initially from up to 10 hospitals in Israel and later in other countries pending approval of local health authorities. Completion of patient enrollment and clinical results are anticipated in 2014.
Professor Eran Goldin, lead investigator for the clinical trial and Director of the Digestive Disease Institute at Shaare Tsedek Hospital in Jerusalem, Israel, stated, “Eotaxin-1 is a novel target which has been validated through extensive pre-clinical and observational clinical studies. The upcoming Phase II study with bertilimumab has been designed to assess the clinical relevance of neutralizing eotaxin-1 in patients with active moderate-to-severe ulcerative colitis.”
Daniel Teper, Pharm. D., CEO of Immune and Stephane Allard, M.D., Chief Medical Officer of EpiCept and designated Chief Medical Officer of the combined company following completion of the proposed merger between EpiCept and Immune, commented, “There is a clear need for alternative biological therapies for patients with ulcerative colitis. The established correlation between eotaxin-1 levels in tissue and the severity of the disease provides an opportunity to select patients most likely to respond to therapy.”
Immune and EpiCept signed a definitive agreement to merge on November 7, 2012 and currently anticipate a closing of the transaction in the second quarter of 2013. Bertilimumab will be the lead clinical stage development drug for the combined company following completion of the proposed merger.