NEW YORK--Synergy Pharmaceuticals, Inc. (OTC BB:SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today the initiation of dosing in a Phase IIa clinical trial of SP-304 in patients with chronic constipation (CC). This is a Phase IIa, randomized, double-blind, placebo-controlled, 14-day repeat, oral, dose-escalation study in patients with chronic constipation. The objectives of the Phase IIa clinical trial with SP-304 are to characterize the safety of SP-304 for 14 days in patients with CC and establish doses for the larger planned Phase IIb trial in CC patients.
“SP-304 offers hope to the millions of patients suffering from CC and other human gastrointestinal conditions, for which there are currently limited treatment options,” said Gary S. Jacob, Ph.D., President and CEO of Synergy. “The initiation of this trial is another major milestone in our development of this drug that we believe has the potential of delivering higher efficacy and a better safety profile than any other competitive product.”
About SP-304
SP-304 is a member of a new class of non-systemic drugs for treatment of chronic constipation (CC), irritable bowel syndrome with constipation (IBS-C) and other GI diseases. SP-304 is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally administered SP-304 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 SP-304 promotes intestinal secretion as well as ameliorating gastrointestinal inflammation.
About Chronic Constipation
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 relief. 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 chronic constipation can experience serious discomfort which adversely affects their ability to work and their quality of life.
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 SP-304 began clinical development in June 2008 for gastro-intestinal disorders. SP-304 is a synthetic analog of the human gastrointestinal hormone uroguanylin, and acts by activating the guanylate cyclase C (GC-C) receptor on epithelial cells of the GI tract. Callisto Pharmaceuticals, Inc. (OTC BB: CLSP) is a principal stock holder of Synergy Pharmaceuticals, Inc. More information is available at http://www.synergypharma.com.
Forward-Looking Statements
Certain statements made in this press release are forward-looking. Such statements are indicated by words such as "expect," "should," "anticipate" and similar words indicating uncertainty in facts and figures. Although Synergy believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations reflected in such forward-looking statements will prove to be correct. As discussed in the Synergy Pharmaceuticals Annual Report on Form 10-K for the year ended December 31, 2009, and other periodic reports, as filed with the Securities and Exchange Commission, actual results could differ materially from those projected in the forward-looking statements as a result of the following factors, among others: uncertainties associated with product development, the risk that products that appeared promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that Synergy will not obtain approval to market its products, the risks associated with dependence upon key personnel and the need for additional financing.