NEW YORK--(BUSINESS WIRE)--
Synergy Pharmaceuticals Inc. (SGYP) today announced the start of its second pivotal phase 3 clinical trial to confirm the safety and efficacy of plecanatide, its lead uroguanylin analog and once-daily oral treatment, in adult patients with chronic idiopathic constipation (CIC).
This phase 3 trial is a randomized, double-blind clinical trial to compare a 12-week, dose-ranging regimen of plecanatide (3.0 and 6.0mg) against placebo in adult patients with CIC. The study will be conducted at approximately 180 sites in the United States and will enroll approximately 1350 patients with CIC. The primary endpoint of the study is the proportion of patients who are overall responders for the 12-week treatment period.
This study will be running in parallel with the first phase 3 CIC trial that was initiated in November 2013. The phase 3 program will enroll a total of approximately 2700 patients with CIC. For more information on these trials, please visit http://clinicaltrials.gov/ct2/show/NCT02122471?term=plecanatide+cic&rank=1 and http://clinicaltrials.gov/ct2/show/NCT01982240?term=plecanatide+cic&rank=3
About Synergy Pharmaceuticals Inc.
Synergy Pharmaceuticals is a biopharmaceutical company focused on the development of novel therapies based on the natural human hormone, uroguanylin, to treat gastrointestinal (GI) diseases and disorders. Uroguanylin is a natural hormone produced by humans in the small intestine and plays a key role in regulating the normal functioning of the digestive tract through its activity on the guanylate cyclase-C (GC-C) receptor. The GC-C receptor is known to be a primary source for stimulating a variety of beneficial physiological responses. Synergy has created two unique analogs of uroguanylin – plecanatide and SP-333 – designed to mimic the natural hormone’s activity on the GC-C receptor and target a variety of GI diseases.
Plecanatide is Synergy’s lead uroguanylin analog in clinical development to treat chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Orally administered plecanatide mimics uroguanylin’s functions by binding to and activating the guanylate cyclase-C (GC-C) receptor to stimulate fluid and ion transit required for normal bowel function. Plecanatide is structured identical to the natural hormone with one key amino acid substitution, resulting in a more potent and heat-stable analog and a binding constant eight times that of uroguanylin. Plecanatide has demonstrated excellent efficacy and a unique tolerability profile in a phase 2b trial with 951 CIC patients that was completed in 2013. For more information, please visit 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," "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, 2012 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.
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