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Microbia Announces Positive Phase 2 Results for Its Investigational,Compound Linaclotide

- Data being presented today at Digestive Disease Week -

CAMBRIDGE, Mass., May 21, 2007 /PRNewswire/ -- Microbia today announced the presentation of data from a Phase 2 study in which linaclotide accelerated colonic transit and improved bowel function in patients with constipation- predominant irritable bowel syndrome (IBS-C). These data also showed linaclotide was well tolerated with a low incidence of adverse events. Linaclotide is a first-in-class compound currently being developed for the treatment of IBS-C, chronic constipation (CC), and other gastrointestinal disorders. Linaclotide is an agonist of the guanylate cyclase type-C receptor and acts by a different mechanism than agents targeting the serotonergic system. The results of this study are being presented today by Mayo Clinic investigator Viola Andresen, M.D. at the Digestive Disease Week conference in Washington, DC.

Study Design and Results

Thirty-six women suffering from IBS-C were evaluated in a double-blind, placebo-controlled study, which consisted of a five-day baseline and a five- day treatment period. The endpoints were measurements of gastrointestinal transit and bowel function. Gastrointestinal transit is the process of moving food or other substances through the intestinal tract. Gastrointestinal transit time is generally delayed in patients with IBS-C and is associated with the symptoms of constipation, such as hard stools. Patients who received linaclotide had a significant acceleration of ascending colon emptying and colonic transit at 48 hours post dose as measured by scintigraphy. Patients receiving linaclotide also showed significant improvements in stool consistency (i.e., stools were less hard), stool frequency, straining, and time to first bowel movement. Measurements of the preceding parameters were statistically significant relative to placebo treatment, with p-values of < 0.05 for each. No significant effects on upper intestinal transit were detected.

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