"These novel findings provide valuable insight into the possible role of cGMP in alleviating intestinal pain and may explain the reduction in intestinal pain observed in patients with IBS-C treated with linaclotide in our Phase 2b studies," said Mark Currie, Ph.D., Senior Vice President, R&D and Chief Scientific Officer at Ironwood.
Linaclotide is a first-in-class compound currently being evaluated for the treatment of IBS-C, chronic constipation (CC), and other gastrointestinal disorders. Linaclotide was designed to exert its effect on the intestine with minimal systemic exposure. Linaclotide is an agonist of guanylate cyclase type-C, a receptor found on the lining of the intestine. 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 constipation-the hallmarks of the condition-throughout the 12-week treatment period. In patients with CC, linaclotide reduced constipation throughout the 4-week study period. Linaclotide was well tolerated at all doses in both Phase 2b studies, with the most common adverse event being diarrhea. A United States patent covering linaclotide composition of matter expires in 2025. In September 2007, Ironwood and Forest Laboratories entered into a 50/50 collaboration to co-develop and co-promote linaclotide in the United States. Ironwood retains exclusive rights to linaclotide outside of North America.
About Irritable Bowel Syndrome (IBS)
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 ann
|SOURCE Ironwood Pharmaceuticals|
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