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Top-line data released on Phase 3 linaclotide trial
January 2016
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TOKYO & CAMBRIDGE, Mass.—The Phase 3 clinical trial of linaclotide, being conducted in Japan in adults with irritable bowel syndrome with constipation (IBS-C), has met its primary endpoints, Astellas Pharma Inc. and Ironwood Pharmaceuticals Inc. announced recently. Linaclotide is a guanylate cyclase‐C (GC‐C) agonist currently approved in the United States for the treatment of adults with IBS-C and chronic idiopathic constipation (CIC). Top-line data from the trial indicate that patients treated with linaclotide showed statistically significant improvement compared to placebo-treated patients for both of the two co-primary endpoints. Astellas plans to submit a new drug application for linaclotide in Japan in 2016.
 
“Linaclotide has now met all primary endpoints in all eight of its Phase 3/3b clinical trials, spanning two indications, three doses and multiple countries,” noted Dr. Mark Currie, chief scientific officer and president of research and development at Ironwood.

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