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

Earlier this fall, in a poster session at the Joint International Neurogastroenterology and Motility Meeting, September 6-8, in Bologna, Italy, Synergy scientists also shared data describing the identification and selection of plecanatide (formerly SP-304) as a superior analog of uroguanylin based on physiochemical properties.

Posters Cited

AMERICAN COLLEGE OF GASTROENTEROLOGY ANNUAL MEETING

October 19-24, 2012, Las Vegas, NV

Orally Administered Plecanatide, A Guanylate Cyclase-C Agonist, Acts in the Lumen of the Proximal Intestine to Facilitate Normal Bowel Movement in Mice and Monkeys. (P451) Authored by Stephen Comiskey, John Foss, Gary Jacob, and Kunwar Shailubhai.

UNITED EUROPEAN GASTROENTEROLOGY WEEK

October 20-24, 2012, Amsterdam, The Netherlands

Orally Administered Plecanatide, A Guanylate Cyclase-C Agonist, Acts in the Proximal Intestine to Stimulate Fluid Secretion to Normalize Bowel Movement. (P1003)

Authored by Stephen Comiskey, John Foss and Kunwar Shailubhai.

JOINT INTERNATIONAL EUROGASTROENTEROLOGY AND MOTILITY MEETING

September 6-8, 2012, Bologna, Italy

Plecanatide, a Superior Analog of Uroguanylin, as an Oral Drug Candidate for Treatment of Gastrointestinal Functional Disorders and Diseases. (P330)

Authored by Andrea Brancale, Gary Jacob and Kunwar Shailubhai.

About Synergy Pharmaceuticals Inc.

Synergy is a biopharmaceutical company focused on the development of new drugs to treat gastrointestinal disorders and diseases. Synergy's lead proprietary drug candidate plecanatide is a synthetic analog of the human gastrointestinal (GI) hormone uroguanylin, and functions by activating the guanylate cyclase C receptor on epithelial cells of the GI tract. Synergy completed a Phase I study of plecanatide in healthy volunteers and a Phase IIa clinical trial in chronic idiopathic constipation (CIC) patients. In October, 2011, Synergy initiated dosing of patients in a major Phase II/III clinical trial of plecanatide to treat CIC. Plecanatide is also being developed to treat irritable bowel syndrome with constipation (IBS-C), with the first trial in IBS-C patients planned for the second half of 2012. Synergy's second GC-C agonist SP-333 is in clinical development to treat inflammatory bowel diseases, and is presently in a Phase I trial in healthy volunteers. More information is available at http://www.synergypharma.com .

About Plecanatide

Plecanatide is a member of a new class of essentially non-systemic drugs, referred to as guanylate cyclase C (GC-C) agonists, that are currently in development to treat CIC and IBS-C. Plecanatide is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally-administered plecanatide binds to and activates GC-C receptors expressed on epithelial cells lining the GI mucosa, resulting in activation of the cystic fibrosis transmembrane conductance regulator (CFTR), and leading to augmented flow of chloride and water into the lumen of the gut. Activation of the GC-C receptor pathway is believed to facilitate bowel movement as well as producing other beneficial physiological responses including improvement in abdominal pain and inflammation. In animal models, oral administration of plecanatide promotes intestinal secretion and also ameliorates GI inflammation.

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