NEW YORK, April 9, 2012 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP) (Nasdaq:SGYPU) (Nasdaq:SGYPW), a developer of new drugs to treat gastrointestinal disorders and diseases, today announced that it has successfully achieved the halfway mark for total enrollment in its ongoing plecanatide Phase II/III clinical trial in chronic idiopathic constipation (CIC) patients. Over 800 patients have been screened at present, resulting in a total of 440 randomized, enrolled patients to date. The trial, designed to enroll 880 patients to achieve 800 evaluable patients, was initiated on October 24, 2011. The Company anticipates completing enrollment of the trial in the third quarter of this year and reporting top line data in the fourth quarter.
"We are pleased with the vigorous pace of enrollment in this ongoing trial and the overall enthusiasm from the more than 100 clinical sites currently engaged in this clinical trial," said Gary S. Jacob, Ph.D, President and Chief Executive Officer of Synergy Pharmaceuticals.
The plecanatide CIC trial, entitled "A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Chronic Idiopathic Constipation - Protocol SP304-20210," includes 3 doses of plecanatide (0.3, 1.0, 3.0 mg) plus a placebo arm. Synergy developed a novel patient reported outcome (PRO) questionnaire for CIC symptoms that is being validated in this study. The primary endpoint is a responder analysis based on improvement in the number of complete spontaneous bowel movements in 9 of the 12 weeks of the treatment period. A nationwide advertising campaign has been launched for this study, with patients directed to the following website www.cicstudy.com or to a call center (1-855-CIC-9200).
Synergy also plans to commence a plecanatide Phase II clinical trial in constipation-predominant irritable bowel syndrome (IBS-C) patients in the second half of 2012. The study is planned to be conducted at 40 U.S. sites and to enroll over 300 patients. The protocol is aligned with the FDA guidance on Clinical Evaluation of Products for the Treatment of IBS-C issued in March, 2010. This will be the first study of plecanatide in this patient population.
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 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 CIC patients. In October, 2011, Synergy initiated dosing of patients in a major Phase II/III clinical trial of plecanatide to treat chronic idiopathic constipation. Plecanatide is also being developed to treat IBS-C, with the first trial in IBS-C patients planned for 2H2012. Synergy's second GC-C agonist SP-333 is currently in pre-clinical development to treat inflammatory bowel diseases. More information is available at http://www.synergypharma.com.
About Plecanatide
Plecanatide is a member of a new class of essentially non-systemic drugs, referred to as guanylate cyclase C (GC-C) agonists, that are currently in development to treat CIC and IBS-C, which includes a first-in-class drug being developed by Ironwood and Forest Labs. 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 Chronic Constipation (CC)
CC is a very common gastrointestinal disorder. Up to 34 million Americans suffer from the disorder, and of this population about 8.5 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 chronic constipation can experience serious discomfort which adversely affects their ability to work and their quality of life.
About Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome (IBS) is 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 U.S. 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.
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. Synergy does not undertake any 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, 2011 and other periodic reports filed with the Securities and Exchange Commission.