Ferring Pharmaceuticals begins phase III trials of elobixibat, a new investigational compound for chronic idiopathic constipation
Ferring Pharmaceuticals today MAY 2, 2013, announced it has initiated enrolment of patients in two phase III clinical trials of the investigational compound 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 enroll 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 potentially increases colonic fluid secretion and motility. 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.”
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 expenditure2. Studies show that nearly 50% of CIC sufferers are not satisfied with available treatments3 underscoring the unmet medical need in this area.
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.
Elobixibat is an IBAT inhibitor, in clinical testing as of December 2012 for the treatment of chronic constipation and irritable bowel syndrome with constipation (IBS-C). It works by blocking the enterohepatic circulation of bile acids, increasing the bile acid concentration in the gut, which accelerates intestinal passage and softens the stool.
The drug was developed by Albireo AB, who licensed it to Ferring Pharmaceuticals for further development and marketing.
Albireo has partnered with Ajinomoto Pharmaceuticals, giving the Japan-based company the rights to further develop the drug and market it throughout Asia.
- “INN for A3309 is ELOBIXIBAT”. AlbireoPharma. Retrieved 5 December 2012.
- H. Spreitzer (27 August 2012). “Neue Wirkstoffe – Elobixibat”. Österreichische Apothekerzeitung (in German) (18/2012): 24.
- “Ferring Pharmaceuticals Acquires Licensing Rights for Elobixibat from Albireo AB”(Press release). Ferring Pharmaceuticals. 3 July 2012.
- “Ajinomoto Pharmaceuticals and Albireo Announce Japan and Asia License Agreement for Elobixibat”. Albireo. Retrieved 5 December 2012.