NEW YORK--Synergy Pharmaceuticals, Inc. (OTC BB: SGYP), a developer of new drugs to treat gastrointestinal disorders (GI) and diseases, announced today that it has been awarded a $244,479 grant under the Qualifying Therapeutic Discovery Project (QTDP) program to aid the Company in its development of plecanatide currently in clinical development to treat gastrointestinal disorders. The QTDP program was created under the Patient Protection and Affordable Care Act of 2010 to provide tax credits or grants for eligible therapeutic discovery projects during tax years 2009 and 2010. To receive this award, Synergy needed to show reasonable potential to treat areas of unmet medical need or produce a new therapy to prevent, detect or treat chronic or acute diseases and conditions; reduce long-term health costs in the US; or significantly advance the goal of curing cancer within a 30-year period.
Synergy's proprietary drug candidate plecanatide has just completed a Phase IIa clinical trial in patients to treat chronic constipation (CC). The Company plans to initiate a Phase IIb 28-day repeated-oral-dose, placebo-controlled clinical trial of plecanatide in CC patients in the first quarter of 2011.
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 GI diseases. 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 Constipation (CC)
CC 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 CC often experience hard stools, straining during bowel movements and not enough bowel movements during the week. People with CC 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.
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 just completed a Phase IIa clinical trial in patients to treat CC. The Company plans to initiate a Phase IIb 28-day repeated-oral-dose, placebo-controlled clinical trial of plecanatide in CC patients in the first quarter of 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 IIb 28-day repeated-oral-dose, placebo-controlled clinical trial of plecanatide in CC patients in the first 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 for the year ended December 31, 2009 and periodic reports filed with the Securities and Exchange Commission.