NEW YORK--Synergy Pharmaceuticals, Inc. (OTCBB: SGYP), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, announced today that on February 1, 2011 the U.S. Patent and Trademark Office issued U.S. Patent No. 7,879,802, covering Synergy’s novel drug candidate SP-333 to treat inflammatory bowel disease (IBD). SP-333 is a second-generation guanylate cyclase C (GC-C) agonist with the potential to treat gastro-intestinal diseases such as ulcerative colitis. The patent entitled "Agonists of Guanylate Cyclase Useful for the Treatment of Gastrointestinal Disorders, Inflammation, Cancer and Other Disorders" specifically claims composition of matter of SP-333 and use in the treatment of human diseases.
"SP-333, to our knowledge, represents the most potent and stable GC-C agonist ever developed," stated Dr. Gary S. Jacob, President and CEO of Synergy Pharmaceuticals. “This issued patent covering SP-333’s composition of matter is a key addition to our intellectual property estate, providing the framework for our plans to pursue GC-C agonists to treat inflammatory bowel diseases such as ulcerative colitis.”
“The science behind SP-333 marks a new approach to the treatment of gastrointestinal anti-inflammatory diseases,” said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy Pharmaceuticals, and senior inventor of SP-333. "In animal studies of GI inflammation, SP-333 at an oral dose as low as 0.05 mg/kg body weight demonstrated superior anti-inflammatory activity compared to 5-aminosalicylic acid (5-ASA) given at a dose of 100 mg/kg. We are excited with SP-333’s impressive anti-inflammatory activity, and are pleased to be the first to patent a drug in this next-generation category of potential therapies for GI inflammatory diseases."
Synergy plans to file an Investigational New Drug (IND) application of this innovative therapy in 2011, and plans to initiate a Phase I trial of SP-333 in healthy volunteers before the end of the year. SP-333 will be the second drug from Synergy’s portfolio of GC-C agonists to enter the clinic.
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 this hormone is predicted to be one of the primary reasons for the formation of polyps that can lead to colon cancer, 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 activation of GC-C. In animal models, oral administration of SP-333 ameliorates GI inflammation by suppressing production of certain pro-inflammatory cytokines.
About Ulcerative Colitis
More than 500,000 Americans are afflicted with ulcerative colitis, a type of IBD that causes chronic inflammation of the colon. Along with Crohn's disease, the other major form of IBD, ulcerative colitis is painful and debilitating, and can lead to other serious and life-threatening complications such as increased incidence of colon cancer. There is currently no medical cure for ulcerative colitis. A considerable medical need exists for the control and treatment of ulcerative colitis.
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 guanylate cyclase C (GC-C) receptor on epithelial cells of the GI tract. Plecanatide has recently completed a Phase IIa clinical trial in patients to treat CC. The company plans to initiate a Phase II/III 90-day repeated-oral-dose, placebo-controlled clinical trial of plecanatide in CC patients in the second quarter of 2011. Plecanatide is also being developed to treat IBS-C, with the first trial in IBS-C patients planned for 2011. 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 CC patients in the second quarter 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/A for the year ended December 31, 2009 and periodic reports filed with the Securities and Exchange Commission.