Synergy Pharmaceuticals, Inc. Completes Screening And Planned Enrollment In Phase IIb/III Study In Chronic Idiopathic Constipation Patients

NEW YORK, Aug. 14, 2012 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal disorders announced today that its Phase IIb/III plecanatide study in chronic idiopathic constipation (CIC) achieved its enrollment target of 880 patients on August 13, 2012. Sites have been notified that screening will close August 16th and enrollment will close at the end of the month.

Synergy designed the trial to include exploration of the low end of the plecanatide dose range in CIC, which is consistent with discussions Synergy has had with FDA. Synergy anticipates topline data being released by year end.

Plecanatide is currently being developed for the treatment of patients suffering with CIC, and with constipation-predominant irritable bowel syndrome (IBS-C). Plecanatide is an agonist of the guanylate cyclase-C (GC-C) receptor and is a superior analog of the natriuretic peptide, uroguanylin, the physiologic ligand of GC-C.

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 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 CIC patients. In October, 2011, Synergy initiated dosing of patients in a major Phase II/III clinical trial of plecanatide to treat chronic idiopathic constipation. Plecanatide is also being developed to treat constipation-predominant irritable bowel syndrome, with the first trial in IBS-C patients planned for the second half of 2012. Synergy's second GC-C agonist SP-333 is currently in pre-clinical development to treat inflammatory bowel diseases. 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, which 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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