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Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies
Date:3/4/2008

- Chronic constipation and IBS-C studies each meet primary endpoint -

CAMBRIDGE, MASS. and NEW YORK, March 4 /PRNewswire-FirstCall/ -- Microbia, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from two Phase 2b randomized, double-blind, placebo-controlled studies assessing the safety, therapeutic effect, and dose response of four different once-daily doses of linaclotide: 75 mcg, 150 mcg, 300 mcg, and 600 mcg. The first study examined the effects of linaclotide in patients with chronic constipation (CC), while the second study examined its effects in patients with irritable bowel syndrome with constipation (IBS-C). Preliminary analysis of the CC study data and an interim analysis of the IBS-C study data indicate that each study met its primary endpoint.

(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )

In the four-week CC study, the primary efficacy endpoint was the change from pre-treatment in weekly spontaneous bowel movement (SBM) frequency rate. During the two-week pre-treatment period, the mean baseline weekly SBM frequency rate across all treatment groups was 2.31. Patients who received once-daily dosing of linaclotide demonstrated a dose-responsive increase in weekly SBM frequency rate ranging from 0.98 (75 mcg, p = 0.09) to 2.99 (600 mcg, p < 0.0001) compared to patients receiving placebo. The response was significant at all doses above 75 mcg. Linaclotide-treated patients also experienced improvements in all other top-line efficacy endpoints-complete spontaneous bowel movement (CSBM) frequency, stool consistency, straining, abdominal pain, bloating, and abdominal discomfort
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SOURCE Microbia, Inc. and Forest Laboratories, Inc.
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