Ironwood and Forest to Present Positive Data From Linaclotide Phase 2b IBS-C Study at ACG Annual Scientific ...( - Comprehensive Phase 3 C...),Health

- Comprehensive Phase 3 Clinical Program Initiated -

CAMBRIDGE, Mass. and NEW YORK, Sept. 23 /PRNewswire-FirstCall/ -- Ironwood Pharmaceuticals (formerly Microbia) and Forest Laboratories, Inc. (NYSE: FRX) today announced they will present results of a Phase 2b study investigating linaclotide's safety and efficacy in 419 patients with irritable bowel syndrome with constipation (IBS-C) in a plenary session at the American College of Gastroenterology (ACG) 2008 Annual Scientific Meeting in Orlando, Fla. on October 7, 2008. Analysis of these data indicated that the study met its primary endpoint. Linaclotide is a first-in-class investigational compound being evaluated for its potential to treat IBS-C, chronic constipation (CC), and other gastrointestinal disorders.

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Ironwood and Forest also announced that they have initiated a comprehensive Phase 3 clinical program to evaluate linaclotide's safety and efficacy in patients with either IBS-C or CC. The program will include two pivotal trials in IBS-C patients and two pivotal trials in CC patients, enrolling over 2,500 patients at approximately 250 clinical centers. The companies recently began patient dosing in the first CC trial and expect to initiate the second CC trial by the end of September, 2008. The companies expect to initiate both IBS-C trials by January, 2009.

IBS-C Phase 2b Study

This U.S. and Canada based, twelve-week, randomized, double-blind, placebo-controlled Phase 2b study was designed to assess the safety, efficacy, and dose-response of linaclotide in patients with IBS-C. Patients were ran
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