NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the appointment of Paul Eng, Ph.D., as Senior Vice President, Drug Development. Dr. Eng will lead all clinical development operations for Synergy’s pivotal phase 3 program with plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
“Dr. Paul Eng brings a considerable amount of recent experience and valuable expertise, having successfully led late-stage clinical programs through NDA and drug approval for chronic idiopathic constipation (CIC) and IBS-C,” said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals. “We are fortunate to have Paul join us and look forward to his contributions as we quickly advance plecanatide into phase 3 registration trials for IBS-C and prepare for a CIC NDA filing next year.”
“I am excited to be joining Synergy at such a critical stage of development,” said Dr. Eng. “Plecanatide has already demonstrated excellent clinical potential for treating IBS-C and CIC patients in phase 2 trials and I look forward to further establishing plecanatide’s efficacy and safety profile in pivotal phase 3 trials.”
Prior to joining Synergy, Dr. Eng was Director of Gastroenterology Clinical Development at Forest Laboratories, Inc., where he was chiefly responsible as study director for the successful pivotal phase 3 clinical trials that led to NDA and drug approval for treatment of CIC and IBS-C. Dr. Eng has a considerable record of achievement in clinical development and medical affairs, with positions at American Home Products (Wyeth) and Life Medical Sciences prior to joining Forest Laboratories in 2001. Dr. Eng holds a Ph.D., Immunology, M.S., Human Genetics and B.S., Physiology from Rutgers University.
Plecanatide is Synergy’s lead uroguanylin analog in late-stage clinical development to treat patients with CIC and IBS-C. Uroguanylin is a natural gastrointestinal (GI) 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. Orally administered plecanatide mimics uroguanylin's functions by binding to and activating the 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. Synergy has successfully completed a phase 2b trial of plecanatide in 951 patients with CIC and is currently enrolling patients in two pivotal phase 3 CIC trials. The company also recently announced positive top-line data results from a phase 2b dose-ranging study with plecanatide in patients with IBS-C.
About Synergy Pharmaceuticals
Synergy Pharmaceuticals (NASDAQ: SGYP) is a biopharmaceutical company focused on the development of novel therapies based on the natural human hormone, uroguanylin, to treat GI diseases and disorders. 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 conditions. SP-333 is currently in phase 2 development for opioid-induced constipation and is also being explored for ulcerative colitis. 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, 2013 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.