DGAP-News: Synergy Pharmaceuticals to Present Study Results From Plecanatide Phase IIb/III Trial in Late-Breaking Clinical Abstract at Digestive Disease Week 2013
(firmenpresse) - Synergy Pharmaceuticals
15.03.2013 10:00
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NEW YORK, 2013-03-15 10:00 CET (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 Orlando, Florida.
The abstract will be presented at the American Gastroenterological Association
(AGA) Institute Late-Breaking Abstract Session on Clinical Science, Tuesday,
May 21st, 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, Ron2; Fogel, Ron3; Koltun, William4; Drossman, Douglas A.5;
Camilleri, Michael6; Mangel, Allen7; Barrow, Laura8; Jacob, Gary S.8;
Shailubhai, Kunwar8.
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(r) (DDW(r)) 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 patientsin 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 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, 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.
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. 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:
Janet Skidmore
Office: 215-658-4915
Mobile: 215-429-2917
skidmorecomm(at)earthlink.net
Investor Contact:
Danielle Spangler
The Trout Group
synergy(at)troutgroup.com
(646) 378-2924
News Source: NASDAQ OMX
15.03.2013 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Synergy Pharmaceuticals
United States
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ISIN: US8716393082
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End of Announcement DGAP News-Service
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