Synergy Pharmaceuticals to Present Poster on SP-333, an Agonist of Guanylate Cyclase-C, Highlighting a Novel Approach to Treating Ulcerative Colitis in Humans Scientific Poster Presentation This Week at ACG 2012 NEW YORK, Oct. 22, 2012 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, today announced a presentation on SP-333, the company's second investigational drug from the guanylate cyclase-C agonist class, at the American College of Gastroenterology 77^th annual meeting, which is being held in Las Vegas, NV from October 19-24, 2012. The presentation highlights pioneering research demonstrating that SP-333 ameliorates colitis in mice through inhibition of NF-kappa B activation. SP-333 recently entered clinical trials as an experimental drug for the treatment of ulcerative colitis, and is presently in a Phase I trial in healthy volunteers. The poster presentation is on Sunday October 21, 2012 from 3:30-7:00PM in Exhibit Hall B at The Venetian. Poster Title:SP-333, a Proteolysis-resistant Agonist of Guanylate Cyclase-C, Inhibits Activation of NF-ĸB and Suppresses Production of Inflammatory Cytokines to Ameliorate DSS-induced Colitis in Mice (P414), authored by Graham Zhang, Krishna P. Arjunan, John A. Foss, Stephen J. Comiskey and Kunwar Shailubhai. "SP-333 is a highly potent oral drug candidate for treatment of GI inflammatory diseases," stated Dr. Gary S. Jacob, President and CEO of Synergy Pharmaceuticals. "SP-333 broadens our clinical portfolio of novel GC-C agonists for treatment of GI disorders and diseases." "The transcription factor NF-ĸappa B is known to be abnormally active in many inflammatory diseases and cancers," said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy Pharmaceuticals. "The study we report here, demonstrating that treatment with SP-333 inhibits activation of NF-kappa B, is an exciting scientific finding that opens a new avenue for treatment of ulcerative colitis. Oral treatment with SP-333, a first-in-class guanylate cyclase-C (GC-C) agonist to treat ulcerative colitis, showed impressive anti-inflammatory activity in experimental models of colitis in mice." About SP-333 SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone which is normally produced in the body's intestinal tract. Deficiency of uroguanylin is likely to be one of the primary reasons associated with formation of polyps as well as debilitating and difficult-to-treat GI inflammatory disorders such as ulcerative colitis and Crohn's disease. Orally-administered SP-333 binds to and activates guanylate cyclase C (GC-C) expressed on epithelial cells lining the GI mucosa, resulting in stimulation of cyclic GMP in target tissues. SP-333 has been found to be highly stable against proteolysis in simulated intestinal fluid for up to 24 hours. Its enhanced stability makes this peptide an extremely potent GC-C agonist in animal studies in mice and monkeys, promoting bowel movement in monkeys, and ameliorating GI inflammation in mice, respectively. 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. 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 constipation-predominant irritable bowel syndrome (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. Forward-Looking Statements 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," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements 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. Investors should read the risk factors set forth in Synergy's Form 10-K for the year ended December 31, 2011 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. CONTACT: Media Contact: Janet Skidmore Office: 215-658-4915 Mobile: 215-429-2917 email@example.com Investor Contact: Danielle Spangler The Trout Group firstname.lastname@example.org (646) 378-2924
Synergy Pharmaceuticals to Present Poster on SP-333, an Agonist of Guanylate Cyclase-C, Highlighting a Novel Approach to
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