Synergy Pharmaceuticals Inc, a biopharmaceutical company focused on the research and development of novel therapies for the treatment of chronic idiopathic constipation, irritable bowel syndrome with constipation and other difficult-to-treat GI conditions,  has closed patient enrollment in its plecanatide phase IIb clinical trial in irritable bowel syndrome with constipation (IBS-C).

The clinical trial is being conducted at approximately 70 sites in the United States and includes four doses of plecanatide (0.3mg, 1.0mg, 3.0mg, 9.0mg) plus a placebo arm, taken once daily over a period of 12 weeks. The primary endpoint is change from baseline in the mean number of complete spontaneous bowel movement (CSBM) over the 12 week treatment period. The first patient was dosed on December 27, 2012 and Synergy anticipates reporting topline data in the beginning of the second quarter of 2014.

Plecanatide is Synergy’s lead guanylate cyclase-C (GC-C) agonist in development to treat patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a 16-amino-acid analog of the human gastrointestinal (GI) hormone, uroguanylin, a natural agonist for the intestinal GC-C receptor. Orally administered plecanatide mimics uroguanylin’s functions by binding to and activating the GC-C receptor to stimulate fluid secretion and transit required for normal digestion. Synergy has successfully completed a phase IIb trial of plecanatide with CIC patients and is currently enrolling patients into its pivotal phase III CIC programme.