NEW YORK, March 15, 2013 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today that study results from the Phase IIb/III Trial of plecanatide, its lead investigational compound for the treatment of chronic idiopathic constipation (CIC), will be featured in a late-breaking oral presentation session at Digestive Disease Week 2013 being held May 18-21 in Orlando, Florida.
Abstract: Plecanatide, a Novel Guanylate Cyclase-C (GC-C) Receptor Agonist, is Efficacious and Safe in Patients with Chronic Idiopathic Constipation (CIC): Results from a 951-Patient, 12-Week, Multi-Center Trial. Minor, Philip B. 1; Surowitz, Ron 2; Fogel, Ron 3; Koltun, William 4; Drossman, Douglas A. 5; Camilleri, Michael 6; Mangel, Allen 7; Barrow, Laura 8; Jacob, Gary S. 8; Shailubhai, Kunwar 8.
1Oklahoma Foundation for Digestive Research, Oklahoma City, OK. 2Health Awareness Inc., Jupiter, FL. 3Clinical Research Institute of Michigan, Chesterfield, MI. 4Medical Center for Clinical Research, San Diego, CA. 5School of Medicine, University of North Carolina, Chapel Hill, NC. 6Mayo Clinic, Rochester, MN. 7RTI, Research Triangle Park, NC. 8Synergy Pharmaceuticals, New York, NY.About Digestive Disease Week Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange County Convention Center, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org . 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 (GC-C) receptor on epithelial cells of the GI tract. Synergy completed a positive Phase I study of plecanatide in healthy volunteers, and positive Phase IIa and Phase IIb/III clinical trials in patients with chronic idiopathic constipation (CIC). Synergy is also developing plecanatide for the treatment of constipation-predominant irritable bowel syndrome (IBS-C), having initiated the first trial in IBS-C patients in late 2012. Synergy's second GC-C agonist, SP-333, is in clinical development to treat inflammatory bowel diseases, and has recently completed its first 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, 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.