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Ferring Pharmaceuticals has announced it has initiated enrolment of patients in two phase III clinical trials of elobixibat for the treatment of chronic idiopathic constipation (CIC), a common gastrointestinal disorder affecting approximately 14% of the general population1. The two studies, Echo 1 and Echo 2, will be conducted at close to 200 sites worldwide and will enrol nearly 1700 patients. The studies aim to demonstrate the efficacy and safety of repeated daily doses of elobixibat against placebo over a period of up to 26 weeks.
Elobixibat is a first-in-class compound with a novel physiological mechanism of action. It acts locally in the gut with minimal systemic exposure to enhance the amount of luminal bile acids in the colon by a partial inhibition of the Ileal Bile Acid Transporter (IBAT). This increases colonic fluid secretion and motility. Phase II clinical trials with elobixibat in patients with CIC have demonstrated clinically meaningful, statistically significant and dose-dependent improvement on key constipation symptoms such as bowel movement frequency, straining and stool consistency2. Ferring acquired the global marketing rights for elobixibat, excluding Japan and a small number of Asian markets, from Albireo AB in 2012.
“We are pleased to begin Phase III studies on elobixibat for the treatment of chronic idiopathic constipation,” said Pascal Danglas, Executive Vice President, Clinical and Product Development at Ferring. “CIC causes significant discomfort to sufferers and seriously impacts their quality of life. Studies have shown that patients are not satisfied with current treatments. With its novel mechanism of action, we believe that elobixibat has the potential to improve medical treatment of CIC sufferers.”
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About chronic idiopathic constipation
Chronic idiopathic constipation (CIC) is among the most common diseases throughout the world, affecting approximately 14% of the general population particularly women and the elderly1. Patients with CIC often experience hard and lumpy stools, straining during defecation and a sensation of incomplete evacuation, as well as discomfort and bloating. CIC adversely affects a person's quality of life and is associated with significant health care expenditure3. Studies show that nearly 50% of CIC sufferers are not satisfied with available treatments4 underscoring the unmet medical need in this area.
About the Elobixibat Research in Constipation (Echo) phase III trials
For further information on the Echo 1 trial, please visit: http://www.clinicaltrials.gov/ct2/show/NCT01827592?term=elobixibat&rank=1
For further information on the Echo 2 trial please visit: http://www.clinicaltrials.gov/ct2/show/NCT01833065?term=elobixibat&rank=2
About Ferring Pharmaceuticals:
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of gastroenterology, reproductive health, urology and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 90 countries. To learn more about Ferring or its products please visit www.ferring.com.
1 Suares NC, Ford AC. Prevalence of, and risk factors for, chronic idiopathic constipation in the community: systematic review and meta-analysis. Am J Gastroenterol. 2011 Sep;106(9):1582-91
2 Chey WD, et al. A Randomized Placebo-Controlled Phase IIb Trial of A3309, A Bile Acid Transporter Inhibitor, for Chronic Idiopathic Constipation. Am J Gastroenterol 2011; 106:1803–1812
3 Sun SX, et al. Impact of Chronic Constipation on Health-Related Quality of Life, Work Productivity, and Healthcare Resource Use: An Analysis of the National Health and Wellness Survey. Dig Dis Sci. 2011 Sep;56(9):2688-95
4 Johanson JF, Kralstein J . Chronic constipation: a survey of the patient perspective . Aliment Pharmacol Ther 2007 ; 25 : 599 – 608
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