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NEW YORK, May 21, 2013 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat patients with gastrointestinal disorders and diseases, today presented positive safety and efficacy results from its large multicenter trial of plecanatide in patients with chronic idiopathic constipation (CIC) at Digestive Disease Week (DDW) in Orlando, FL.
The data were presented at the Late-Breaking Abstract Session of the American Gastroenterological Association (AGA) by lead author Dr. Philip B. Miner, President and Medical Director of the Oklahoma Foundation for Digestive Research.
Plecanatide, Synergy's investigational drug for the treatment of CIC and irritable bowel syndrome with constipation (IBS-C), is a guanylate cyclase-C (GC-C) agonist. This novel drug mimics the function of the natural human peptide hormone, uroguanylin.
The clinical trial was designed to evaluate whether plecanatide could increase the number of complete spontaneous bowel movements (CSBMs), as well as benefit other bowel measures associated with the constipated state such as stool consistency and straining, along with general quality of life, in people with CIC. In the study, 951 patients with CIC were randomized to four study arms to determine the efficacy and safety of three oral doses of plecanatide (0.3, 1.0, or 3.0 mg, daily), compared to placebo, over the course of a 12-week dosing regimen.
"All three doses of plecanatide demonstrated statistically significant improvement in the number of complete, spontaneous bowel movements experienced by study participants who responded to treatment," said Dr. Miner. "In addition to increased frequency of CSBMs, participants reported improvements in other symptoms of chronic constipation, including decreased stool hardness and straining. All doses of plecanatide appeared to be safe and well tolerated, and safety data were consistent with Synergy's previous Phase I and IIa trials of plecanatide."
"We are very pleased to share these compelling new data at DDW supporting the efficacy and safety of plecanatide as a potential new treatment for patients suffering with CIC," said Dr. Gary S. Jacob, President and CEO of Synergy. "We are moving full-speed ahead with development of plecanatide to treat CIC, and plan to initiate pivotal trials in the second half of 2013. In addition, we presently have a Phase 2b trial of plecanatide in IBS-C patients underway and expect to release top-line data in 1Q2014."