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RHEINFELDEN, Switzerland, Oct. 11, 2017 – Full results of the phase III clinical study investigating a high strength 1600 mg oral formulation of mesalazine for the treatment of mild to moderate ulcerative colitis (UC) have been published in the international journal Alimentary Pharmacology & Therapeutics.1 In Europe, up to three million people suffer from inflammatory bowel diseases, such as UC, which can strongly reduce their quality of life.2 The aim of the double-blinded trial, sponsored by Tillotts Pharma AG (“Tillotts”), was to compare the efficacy and safety of the 1600 mg tablet against 400 mg tablet mesalazine formulations. Full results show that the primary objective of the study was met.1
The trial, led by Prof. Geert D’Haens, University of Amsterdam, was conducted in more than 800 patients with mild to moderate active UC at almost 180 centres in Europe and Canada. This makes it the largest trial of mesalazine induction therapy performed to date.1 Patients were randomised to 3.2 g of oral mesalazine, administered as two 1600 mg tablets once-daily or four 400 mg tablets twice-daily. Investigators, central readers, and patients were unaware of treatment assignment.
“Tillotts is committed to innovation. We leverage our expertise in drug delivery and controlled-release formulation to help patients improve their quality of life,” says Thomas A. Tóth von Kiskér, CEO at Tillotts. “This trial underscores our continued commitment to offer patients a wide range of treatments for disorders of the digestive system. This is a milestone for Tillotts and I would like to thank all patients, physicians and nurses who participated in making it possible”.
This study was the first trial of high strength mesalazine using central reading and blinded endoscopic video assessment.1 This ensures strict adherence to trial inclusion criteria and an unbiased interpretation of endoscopic imaging.3,4 Such an independent review of imaging endpoints is now required by regulatory agencies and is considered to be indispensable for phase III UC trials.3
UC is an inflammatory bowel disease (IBD) that involves chronic inflammation of the lining of the large bowel. In Europe, up to three million people suffer from IBDs, such as UC, which can strongly reduce their quality of life. Unlike Crohn’s disease, which can occur anywhere along the digestive tract, UC only affects the colon and rectum. UC causes swelling of the intestinal wall, in addition to ulceration of the large intestine. Symptoms vary, but often include abdominal pain and diarrhoea. UC is a chronic debilitating disease that may lead to life-threatening complications.
About Prof. Geert D’Haens
Geert D’Haens is professor of gastroenterology at the Academic Medical Center at the University of Amsterdam, where he leads a group of more than 35 IBD researchers. He is one of the founders of ECCO, the European Crohn’s and Colitis Organization. Presently, he is also Director of European Operations of Robarts Clinical Trials and chairman of IOIBD, the international organization for study of IBD. He has authored more than 300 peer reviewed articles so far.
For more information, contact Federica Ricatto, Senior Communications Manager, Medical Affairs:
Phone: +41 61 935 2749
The press release is available in German here
About Tillotts Pharma AG
Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with approximately 300 employees in Switzerland and abroad. Tillotts is engaged in advancing care and is committed to making a difference for the millions of people worldwide who suffer from GI-diseases. GI-health is our passionTM. All trademarks used or mentioned here are protected by law.
Zeria Pharmaceutical Co., Ltd., founded in 1955, based in Tokyo, Japan, operates internationally through a number of subsidiaries in the Ethical Pharmaceuticals and Consumer Healthcare businesses. Zeria is dedicated to research and development of pharmaceutical products and is specialised in the gastroenterology field, among others. The company is listed on the First Section of Tokyo Stock Exchange (Stock code: 4559).
© Copyright Tillotts Pharma AG. All rights reserved.
1. D’Haens GR, Sandborn WJ, Zou G, et al., Randomised non-inferiority trial: 1600 mg versus 400 mg tablets of mesalazine for the treatment of mild-to-moderate ulcerative colitis, Aliment Pharmacol Ther. 2017 Aug;46(3):292-302.
2. Kaplan, G. The global burden of IBD: from 2015 to 2025. Nat Rev Gastroenterol Hepatol. 2015;12(12):720-7
3. Gottlieb K, Feagan BG, Sandborn WJ, MD, et al., Central Reading of Endoscopy Endpoints in Inflammatory Bowel Disease Trials, Inflamm Bowel Dis. 2015 Oct;21(10):2475-82.
4. Feagan BG, Sandborn WJ, D’Haens G, et al., The role of centralized reading of endoscopy in a randomized controlled trial of mesalamine for ulcerative colitis, Gastroenterology. 2013;145:149-157.