BETHESDA, MD – May 16, 2005 – Takeda Pharmaceuticals North America (TPNA) and Sucampo Pharmaceuticals announced the initiation of a phase III clinical development program for lubiprostone in patients with constipation-predominant irritable bowel syndrome (IBS-C). Enrollment for these trials begins this month. Lubiprostone is an investigational compound currently being evaluated by the FDA for the treatment of chronic idiopathic constipation and associated pain and bloating in adults.
The IBS-C clinical development program will include two phase III trials. Each trial will examine more than 500 patients for 12 weeks to evaluate the safety and efficacy of lubiprostone.
“Irritable bowel syndrome is a condition that can impact a person’s quality of life, but is currently addressed by few available therapies,” said John Johanson, M.D., clinical associate professor, University of Illinois College of Medicine, and principal investigator. “Based on results from our phase II study, we believe lubiprostone may have the potential to treat IBS-C, and thus offer a new option for people living with irritable bowel syndrome.”
The program includes two double-blind, randomized phase III clinical trials with a treatment period of 12 weeks, taking place at up to 130 sites around the United States. A previous phase II study in IBS-C patients evaluated the effectiveness across a range of doses. Additionally, studies of lubiprostone in chronic constipation have achieved clinical endpoints of relief of constipation and associated pain and bloating and demonstrated tolerability, regardless of gender.
Lubiprostone is a chloride channel activator, a novel compound with a unique mechanism of action. Taken orally, the agent has been shown to work locally and specifically in the GI tract by activating a specific chloride channel (CLC2 ). Chloride channels are proteins that carry chloride on cells lining the small intestine. When activated, these cells increase intestinal fluid secretion. This increased fluid secretion improves stool frequency and consistency that could result in reduced abdominal discomfort, pain and bloating.
“This new phase of the clinical development for lubiprostone marks another significant milestone for Sucampo and Takeda because it follows so closely on the heels of our NDA submission for chronic constipation in March,” said George Perentesis, M.D., vice president of Research and Development at Sucampo. “Results from this new phase of lubiprostone research will enable us to evaluate the feasibility of pursuing an IBS-C indication for this compound and possibly offering another option for people who live with this condition.”
For more information about enrollment, call 1-301-961-3400.
About Irritable Bowel Syndrome
IBS is a chronic disorder characterized by the multiple symptoms of abdominal pain and discomfort, bloating, and extreme changes of bowel habits such as constipation and/or diarrhea. IBS is considered to be one of the most common gastrointestinal disorders. It is reported that approximately 30 million people in North America meet the diagnostic criteria for IBS. There are currently few choices of treatment available for the multiple symptoms of IBS. According to the American Gastroenterological Association, the cause of IBS is not known, although lifestyle factors or psychological stress may play a role. Patients diagnosed with IBS are commonly classified as having constipation-predominant IBS, diarrhea-predominant IBS or alternating IBS (alternating between constipation and diarrhea). The condition causes a great deal of discomfort and distress for its sufferers. While not life threatening, it can significantly interfere with daily activities and reduce their quality of life.
Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc. is a pharmaceutical company that concentrates on developing compounds from its proprietary functional fatty acid technology platform, which consists of exclusive rights in the Americas to a portfolio of more than 650 patents. The company, founded in 1996 by Dr. Ryuji Ueno and Dr. Sachiko Kuno in Bethesda, MD, focuses principally on developing novel therapies for gastrointestinal, liver and circulatory indications, and is strategically selecting and developing candidates for other indications. Sucampo’s functional fatty acid platform is based on the discoveries of Company Founder, Dr. Ryuji Ueno. To learn more about Sucampo, visit www.sucampo.com.
Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes and cholesterol-lowering treatments. Through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, sleep, cardiovascular disease and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com .
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