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Synergy Pharmaceuticals Highlights Mechanistic Features Of Plecanatide, A Novel Investigational Drug For Chronic Idiopathic Constipation

NEW YORK, Oct. 22, 2012 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, today announced the preclinical findings being presented by Synergy scientists at two key gastroenterology congresses this week.

The scientific poster presentations describe the site of action and other mechanistic features of plecanatide, Synergy's investigational drug for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is an agonist of the guanylate cyclase-C receptor and an analog of the natriuretic peptide, uroguanylin, the physiologic ligand of GC-C. As a uroguanylin analog, plecanatide is a member of a new class of non-systemic oral drugs, known as guanylate cyclase-C (GC-C) agonists, that act locally to promote intestinal fluid secretion.

"These preclinical studies helped to define plecanatide as a superior candidate for clinical testing in patients with chronic constipation," said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy Pharmaceuticals, who is presenting the data at the America College of Gastroenterology annual meeting in Las Vegas, NV this week.

"In phase I and early phase II clinical testing, plecanatide exhibited an excellent safety profile, and patients in the phase IIa trial experienced relief from constipation without any remarkable diarrhea," said Stephen Comiskey, Synergy's Vice President for Product Development, who is presenting the preclinical data at the 20 th United European Gastroenterology Week in Amsterdam, The Netherlands this week. "This summer Synergy achieved target enrollment in an ongoing phase IIb/III clinical trial of plecanatide in patients with chronic constipation, and we look forward to the results later this year."

Key preclinical findings being presented that informed the clinical testing of plecanatide as an optimal drug candidate include:
  • Orally administered plecanatide acts primarily in the proximal intestine to stimulate water secretion essential for normalizing bowel movement.
  • In vitro binding studies demonstrate that plecanatide binds to the same receptors in the proximal intestine as human uroguanylin.
  • Plecanatide is highly stable and potent, with even greater affinity for the human GC-C receptors than the natural uroguanylin hormone.

"There is a compelling need to find safe and effective treatments for patients with CIC," said Douglas Drossman, Adjunct Professor of Medicine and Psychiatry and Co-Director Emeritus, UNC Center for Functional GI and Motility Disorders, UNC School of Medicine. "I am encouraged by the preclinical and early phase clinical data that demonstrate proof of concept for plecanatide as a treatment approach for chronic constipation, and look forward to seeing data from the ongoing trials."

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