Synergy Pharmaceuticals, Inc. (OTC BB:SGYP), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, announced that the next clinical trial of plecanatide to treat chronic idiopathic constipation patients, planned to begin in the second quarter of 2011, has been designed as a Phase II/III trial. The trial, a 90-day repeat oral dose ranging, randomized, double-blind, placebo-controlled study, will utilize approximately 800 chronic constipation patients, and will have as its primary objective the measure of complete spontaneous bowel movements (CSBM's) using a responder analysis. The trial will also evaluate spontaneous bowel movements (SBM's) and daily constipation symptoms including straining, stool consistency, abdominal discomfort, plus impact of plecanatide on disease specific quality of life measures.

Synergy recently announced positive results in a Phase IIa clinical trial of plecanatide in patients with chronic constipation. Oral plecanatide given once daily, over 14 consecutive days, at doses of 0.3, 1.0, 3.0 and 9.0 mg improved bowel function in patients with chronic constipation. Benefits were observed in increased frequency of bowel movements, decreased straining and abdominal discomfort, and improvement in other associated clinical measures. Plecanatide treatment exhibited an excellent safety profile. No severe adverse events were observed, and notably no patients receiving plecanatide reported drug-related diarrhea. Additionally, no systemic absorption of plecanatide was detected in patients at any of the dose levels studied.

"Based on recent discussions we have had with FDA plus our analysis of the overall results of our Phase IIa trial of plecanatide, we believe that plecanatide offers us a unique opportunity to accelerate the drug's development by designing the next clinical trial of plecanatide to meet the key endpoint for an approval in chronic constipation, namely, a CSBM responder analysis over a 90-day treatment period in chronic constipation patients," said Gary S. Jacob, President & CEO.

About Plecanatide

Plecanatide (formerly called SP-304) is a member of a new class of non-systemic drugs for treatment of CC, constipation-predominant-irritable bowel syndrome (IBS-C) and other functional GI disorders. 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 guanylate cyclase C (GC-C) 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, facilitating bowel movement. In animal models, oral administration of plecanatide promotes intestinal secretion as well as ameliorating gastrointestinal inflammation.

About Chronic Idiopathic Constipation (CIC)

CIC is a very common gastrointestinal disorder. Up to 26 million Americans suffer from the disorder, and of this population about 5 million have a severe condition necessitating intervention. The prevalence of the disorder is similar in other developed countries. Patients with CIC often experience hard stools, straining during bowel movements and not enough bowel movements during the week. People with CIC can experience serious discomfort which adversely affects their ability to work and their quality of life.

About Irritable Bowel Syndrome (IBS)

Up to one sixth of adults experience irritable bowel syndrome (IBS), a condition marked by disturbed bowel function and abdominal pain. IBS patients can have three different sets of symptoms; diarrhea-predominant (IBS-D), constipation-predominant (IBS-C) and mixed or alternating disorder (IBS-M). The split in prevalence between the forms is about 1/3rd each. In addition, most patients suffering from the mixed form of IBS (IBS-M) are believed to mainly have constipation. An estimated 10 million people in the US and an additional 10 million people in the EU suffer from IBS-C. IBS (all forms) accounts for 12% of adult visits to primary care physicians in the US.

Synergy Pharmaceuticals, Inc.