Synergy Pharmaceuticals, Inc. (OTCQB:SGYP.PK), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, announced today that it has successfully completed preclinical in vitro research demonstrating the inhibition of bile acid uptake by GC-C agonists and that it plans to commence animal studies shortly. Synergy believes this is the first time that GC-C agonists have been shown to potentially lower cholesterol. Synergy has filed a patent application covering the use of proprietary GC-C agonists as drug candidates for prevention and treatment of cholesterol lowering, heart stroke, atherosclerois, diabetes type II, coronary heart disease, gallstones, hypertension, obesity and other cardiovascular diseases. In addition, GC-C agonists may also be used in combination with statins to produce synergistic effect to reduce the dose of statins such as Lipitor®, Zocor® and Crestor® to lower cholesterol. “We are pleased to announce expansion of our GC-C agonist technology to lower cholesterol and are planning to develop a drug candidate for this indication,” said Dr. Gary S. Jacob, CEO of Synergy. “We believe that the use of GC-C agonists to inhibit reabsorption of bile acids represents a novel avenue to develop a new class of safe and oral drugs for treatment of hypercholesterolemia and other cardiovascular diseases,” said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy. “It is well documented that dietary or pharmacological manipulation of the enterohepatic circulation of either cholesterol or bile acids can potentially cause marked changes in plasma cholesterol levels.” About GC-C Agonists GC-C agonists are a new class of non-systemic drugs currently being developed to treat chronic constipation, constipation-predominant-irritable bowel syndrome (IBS-C) and other functional GI disorders. Plecanatide, Synergy’s lead GC-C agonist in clinical development, 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 expressed on epithelial cells lining the GI mucosa, resulting in activation of the cystic fibrosis transmembrane conductance regulator, 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 Synergy Pharmaceuticals, Inc.Synergy is a biopharmaceutical company focused on the development of new drugs to treat gastrointestinal disorders and diseases. Synergy's proprietary drug candidate plecanatide is a synthetic analog of the human gastrointestinal hormone uroguanylin, and functions by activating the GC-C receptor on epithelial cells of the GI tract. Plecanatide has recently completed a Phase IIa clinical trial in patients to treat chronic constipation. Synergy plans to initiate a Phase II/III 90-day repeated-oral-dose, placebo-controlled clinical trial of plecanatide in chronic constipation patients in the second half of 2011. Plecanatide is also being developed to treat IBS-C, with the first trial in IBS-C patients planned for 2012. More information is available at http://www.synergypharma.com. Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements, including Synergy’s plan to initiate a Phase II/III 90-day repeated-oral-dose, placebo-controlled clinical trial of plecanatide in chronic constipation patients in the second half of 2011, are based on Synergy's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Synergy does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Synergy's Form 10-K for the year ended December 31, 2010 and periodic reports filed with the Securities and Exchange Commission.