Synergy Pharmaceuticals to Present Study Results From Plecanatide Phase
IIb/III Trial in Late-Breaking Clinical Abstract at Digestive Disease Week
NEW YORK, March 15, 2013 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals, Inc.
(Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal disorders
and diseases, announced today that study results from the Phase IIb/III Trial
of plecanatide, its lead investigational compound for the treatment of chronic
idiopathic constipation (CIC), will be featured in a late-breaking oral
presentation session at Digestive Disease Week 2013 being held May 18-21 in
The abstract will be presented at the American Gastroenterological Association
(AGA) Institute Late-Breaking Abstract Session on Clinical Science, Tuesday,
May 21^st, 10:00 a.m. EDT, in room 303ABC of the Orange County Convention
Center. Lead author Dr. Philip B. Miner Jr., President and Medical Director of
the Oklahoma Foundation for Digestive Research, will present the abstract on
behalf of Synergy.
Abstract: Plecanatide, a Novel Guanylate Cyclase-C (GC-C) Receptor Agonist,
is Efficacious and Safe in Patients with Chronic Idiopathic Constipation
(CIC): Results from a 951-Patient, 12-Week, Multi-Center Trial. Minor,
Philip B.^1; Surowitz, Ron^2; Fogel, Ron^3; Koltun, William^4; Drossman,
Douglas A.^5; Camilleri, Michael^6; Mangel, Allen^7; Barrow, Laura^8; Jacob,
Gary S.^8; Shailubhai, Kunwar^8.
^1Oklahoma Foundation for Digestive Research, Oklahoma City, OK. ^2Health
Awareness Inc., Jupiter, FL. ^3Clinical Research Institute of Michigan,
Chesterfield, MI. ^4Medical Center for Clinical Research, San Diego, CA.
^5School of Medicine, University of North Carolina, Chapel Hill, NC. ^6Mayo
Clinic, Rochester, MN. ^7RTI, Research Triangle Park, NC. ^8Synergy
Pharmaceuticals, New York, NY.
About Digestive Disease Week
Digestive Disease Week® (DDW®) is the largest international gathering of
physicians, researchers and academics in the fields of gastroenterology,
hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the
American Association for the Study of Liver Diseases (AASLD), the American
Gastroenterological Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the
Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange
County Convention Center, FL. The meeting showcases more than 5,000 abstracts
and hundreds of lectures on the latest advances in GI research, medicine and
technology. More information can be found at www.ddw.org.
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 (GC-C) receptor on epithelial cells of the GI tract.
Synergy completed a positive Phase I study of plecanatide in healthy
volunteers, and positive Phase IIa and Phase IIb/III clinical trials in
patients with chronic idiopathic constipation (CIC). Synergy is also
developing plecanatide for the treatment of constipation-predominant irritable
bowel syndrome (IBS-C), having initiated the first trial in IBS-C patients in
late 2012. Synergy's second GC-C agonist, SP-333, is in clinical development
to treat inflammatory bowel diseases, and has recently completed its first
Phase I trial in healthy volunteers. More information is available at
Plecanatide is a member of a new class of essentially non-systemic drugs,
referred to as guanylate cyclase-C (GC-C) agonists, which are currently in
development to treat CIC and IBS-C. 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.
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, 2011 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.
CONTACT: Media Contact:
The Trout Group
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