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news.Microbia and Forest Laboratories have presented positive top-line results from two Phase IIb randomized, double-blind, placebo-controlled studies assessing the safety, therapeutic effect, and dose response of four different once-daily doses of linaclotide, 75mcg, 150mcg, 300mcg, and 600mcg.
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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.
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 (75mcg, p = 0.09) to 2.99 (600mcg, p < 0.0001) compared to patients receiving placebo. The response was significant at all doses above 75mcg. Patients with IBS-C who received once-daily treatment with linaclotide experienced a significant increase in weekly complete spontaneous bowel movement frequency rate - the primary endpoint for this study - at all doses except for 15mcg.