Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase ... (-that were statistically significant for...)

Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies

Date:3/4/2008

-that were statistically significant for at least two of the four linaclotide dose groups for each endpoint. Linaclotide was well tolerated at all doses with no serious adverse events in any patient during the treatment period. The most common adverse event was diarrhea, which was dose-related and ranged from 4.8 percent to 14.3 percent in the linaclotide-treated patients compared to 2.9 percent of placebo-treated patients. Diarrhea resulted in discontinuation of 2.5 percent of linaclotide-treated patients and no placebo-treated patients. At this time the companies have reviewed only top-line results and further analyses will be conducted in the coming weeks.

An interim analysis of the recently completed 12-week IBS-C study was carried out to enable timely dose selection for Phase 3 trials. The interim analysis was performed on the unlocked database for this study, following the last patient's last visit. Patients with IBS-C who received once-daily treatment with linaclotide experienced a significant increase in weekly CSBM frequency rate-the primary endpoint for this study-at all doses except for 150 mcg. Linaclotide-treated patients also experienced improvements in all other top-line efficacy endpoints-SBM frequency, stool consistency, abdominal pain, bloating, abdominal discomfort, adequate relief, and IBS-C symptom severity-that were statistically significant for at least two of the four linaclotide dose groups for each endpoint. Linaclotide was well tolerated at all doses; there was one serious adverse event in a linaclotide-treated patient which was considered unrelated to treatment by the investigator. The most common adverse event was diarrhea, and diarrhea was the most common adverse event resulting in discontinuation. Once the full analysis of the data is completed, Microbia and Forest Laboratories plan to present the results of these trials at an appropriate scientific conference.

Based on these data and subject to a complete review of the f
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SOURCE Microbia, Inc. and Forest Laboratories, Inc.
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