Ironwood and Forest Present Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Const
October 07 2008 - 8:00AM
PR Newswire (US)
- Data Presented Today at ACG Annual Scientific Meeting - ORLANDO,
Fla., Oct. 7 /PRNewswire-FirstCall/ -- Ironwood Pharmaceuticals,
Inc. (formerly Microbia, Inc.) and Forest Laboratories, Inc.
(NYSE:FRX) today announced the presentation of results from a Phase
2b study assessing linaclotide's safety and efficacy in 420
patients with irritable bowel syndrome with constipation (IBS-C).
Analysis of the data indicates that once- daily oral dosing of
linaclotide, across a range of doses, significantly reduced
abdominal pain and significantly improved constipation symptoms in
patients with IBS-C throughout the 12-week study period. Further,
the safety and tolerability profile support advancing this novel
compound into Phase 3 clinical trials. The study results were
presented today in a plenary session at the American College of
Gastroenterology (ACG) 2008 Annual Scientific Meeting in Orlando,
Fla. (Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
) "Patients with IBS-C are in need of effective and well tolerated
therapies. The results of this study showing improvement in
abdominal pain and constipation are encouraging," said Douglas
Drossman, M.D., Professor of Medicine and Psychiatry at UNC School
of Medicine, Division of Gastroenterology and Hepatology and
Co-Director of the UNC Center for Functional GI & Motility
Disorders, University of North Carolina at Chapel Hill, N.C. Study
Results 420 patients were randomized into the study and 337
completed the 12-week treatment period. At all linaclotide dose
levels, the change from baseline vs. placebo for complete
spontaneous bowel movement (CSBM) frequency-the study's primary
endpoint-was clinically and statistically significant (2.5 to 3.6
vs. 1.0; p = 0.0036 to
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