Date: 2015-11-17
Type of information: Recruitment of the first patient
phase: 2
Announcement: recruitement of the first patient
Company: Immune Pharmaceuticals (Israel - USA)
Product: bertilimumab
Action
mechanism: monoclonal antibody. Bertilimumab (also known as iCo-008 or CAT-213) is a human immunoglobulin monoclonal antibody targeting eotaxin-1, a member of the chemokine family of proteins that act as messenger molecules between the cells of the immune system. Bertilimumab may be indicated for inflammatory disorders including inflammatory bowel disease (Crohn\'s Disease and ulcerative colitis), severe asthma, and orphan dermatological conditions such as bullous pemphigoid. Immune Pharmaceuticals has licensed bertilimumab (iCo-008) for systemic uses, pursuant to an option agreement with iCo Therapeutics. iCo licensed the exclusive world-wide rights to bertilimumab in 2006 from MedImmune Limited (formerly known as Cambridge Antibody Technology Limited), the Global Biologics Unit of AstraZeneca. iCo has retained the rights to develop the ophthalmic indications of bertilimumab including severe ocular allergies (vernal & atopic keratoconjunctivitis) and wet-age related macular degeneration.
Disease: moderate-to-severe ulcerative colitis
Therapeutic area: Autoimmune diseases - Inflammatory diseases
Country: Israel
Trial
details: 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. Ninety patients are expected to be enrolled into the study, sixty of whom will be treated with bertilimumab 7mg/kg and thirty 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 6 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 ten hospitals in Israel and later in other countries pending approval of local health authorities.
Latest
news: * On November 17, 2015, Immune Pharmaceuticals announced that the first patient has been enrolled into the Phase 2 clinical trial evaluating the safety and efficacy of bertilimumab in Ulcerative Colitis (UC). 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. To date, in previously conducted Phase 1 single dose clinical trials, bertilimumab demonstrated initial safety and tolerability as well as dose dependent biological activity. * On June 25, 2015, Immune Pharmaceuticals announced that it has initiated its Phase II Ulcerative Colitis clinical trial. The bertilimumab Phase II Ulcerative Colitis clinical trial is designed as a double blind placebo controlled trial in 42 patients, with moderate to severe disease. Ulcerative Colitis is a chronic inflammatory bowel disease (IBD) that causes long-lasting inflammation and ulcers in the digestive tract and affects around 2 million people worldwide according to a Global Data Report. Primary end points are safety and efficacy, measured by a reduction in the Mayo Clinic Ulcerative Colitis Disease Index at 8 weeks. Secondary end points include assessment of mucosal injury and clinical remission. Patients are selected based on Mayo score and high levels of tissue eotaxin-1 as well as other standardized clinical criteria. The completion of the clinical is expected by the end of 2016. * On September 18, 2014, Immune Pharmaceuticals announced that it has initiated the screening of patients for a Phase II proof of concept clinical trial exploring the safety and efficacy of bertilimumab in the treatment of ulcerative colitis. * On February 21, 2013, Immune Pharmaceuticals, a privately held Israeli company, and EpiCept Corporation have 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. The clinical trial will evaluate the safety, clinical efficacy, and pharmacokinetic profile of bertilimumab in subjects with active moderate-to-severe ulcerative colitis. Ninety patients are expected to be enrolled into the study. 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.\"
