Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase ... (ullresults for both completed studies th...)

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

Date:3/4/2008

ull results for both completed studies, the companies intend to initiate Phase 3 trials in both CC and IBS-C patients in the second half of 2008.

CC Trial Design

The U.S. based Phase 2b study was designed to assess the safety, efficacy, and dose-response of linaclotide in patients with CC. The primary efficacy endpoint was the change in the overall mean weekly frequency of SBMs from the pre-treatment baseline through the four-week treatment period. Following a no-drug washout period of 14-17 days, patients (N=310, with equal randomization across treatment groups) were randomized to receive placebo or linaclotide once-daily in the morning at doses of 75 mcg, 150 mcg, 300 mcg or 600 mcg for 28 days. Following completion of the four weeks of double-blind treatment, patients were followed up for safety assessments for an additional two weeks. Bowel function measurements included the number of spontaneous and complete spontaneous bowel movements (CSBM) compared to baseline, stool consistency using the Bristol Stool Form Scale (BSFS), and straining. Patient-reported outcomes included measures of abdominal pain, abdominal discomfort, and bloating on a daily basis, and constipation severity and overall relief of constipation on a weekly basis. In addition, the use of rescue medication, end-of-treatment satisfaction, and disease-specific quality of life were assessed.

IBS-C Trial Design

The U.S. and Canadian based Phase 2b study was designed to assess the safety, efficacy, and dose-response of linaclotide in patients with IBS-C. The primary efficacy endpoint was the change in the overall mean weekly frequency of CSBMs from the pre-treatment baseline through the 12-week treatment period. Following a no-drug washout period of 14-17 days patients (N=420, with equal randomization across treatment groups) were randomized to receive placebo or linaclotide once-daily in the morning at doses of 75 mcg, 150 mcg, 300 mcg or 600 mcg for 12 weeks. Following c
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Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase ...(ullresults for both completed studies th...),Health