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| Ironwood Pharmaceuticals is developing linaclotide, a novel agent for the treatment of irritable bowel syndrome with constipation (IBS-C), chronic constipation (CC), and other gastrointestinal disorders. |
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| Linaclotide is a first-in-class compound in clinical development for the treatment of IBS-C and CC. Linaclotide demonstrated proof of concept in a comprehensive Phase 2b program, comprised of two clinical studies in over 700 patients with either IBS-C or CC. In patients with IBS-C, linaclotide reduced abdominal pain and relieved bowel dysfunction—the hallmarks of the condition—throughout the 12-week treatment period. Patients with CC who received linaclotide experienced a statistically significant improvement in bowel function, as measured by the study’s primary endpoint. Linaclotide was well tolerated at all doses, with the most common adverse event being diarrhea. |
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| Linaclotide is an agonist of guanylate cyclase type-C, a receptor found on the lining of the intestine. In preclinical testing linaclotide was shown to decrease visceral pain, increase fluid secretion into the intestine, and accelerate intestinal transit. Linaclotide is orally delivered and was designed to exert its effect on the intestine with minimal systemic exposure. |
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| Ironwood and Forest Laboratories have a 50/50 partnership in the United States to co-develop and co-market linaclotide. Ironwood retains exclusive rights to linaclotide outside of North America. |
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IBS-C: Phase 3 in H2 ‘08
CC: Phase 3 |
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| One out of six adults in developed countries suffers from IBS, a chronic condition marked by abdominal pain and disturbed bowel function. IBS accounts for 12% of adult visits to primary care physicians and is the most common disorder diagnosed by gastroenterologists. Healthcare costs associated with IBS exceed $25 billion annually. IBS patients fall largely into three subgroups—constipation-predominant (IBS-C), diarrhea-predominant (IBS-D), and mixed IBS(IBS-M)—and 30% to 40% of these patients suffer from IBS-C. There are currently few available therapies to treat the nine million U.S. patients diagnosed with IBS-C. |
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| As many as 26 million Americans suffer from CC. Patients with CC often experience hard and lumpy stools, straining during defecation, a sensation of incomplete evacuation, and fewer than three bowel movements per week. The discomfort of CC significantly affects patients’ quality of life by impairing their ability to work and participate in typical daily activities. |
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