Synergy Pharmaceuticals Closes Enrollment for Plecanatide Phase 2b Trial in
Patients with IBS-C
NEW YORK -- December 24, 2013
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced it has closed
patient enrollment in its plecanatide phase 2b clinical trial in irritable
bowel syndrome with constipation (IBS-C).
The clinical trial is being conducted at approximately 70 sites in the United
States and includes four doses of plecanatide (0.3mg, 1.0mg, 3.0mg, 9.0mg)
plus a placebo arm, taken once daily over a period of 12 weeks. The primary
endpoint is change from baseline in the mean number of complete spontaneous
bowel movement (CSBM) over the 12 week treatment period. The first patient was
dosed on December 27, 2012 and Synergy anticipates reporting topline data in
the beginning of the second quarter of 2014.
For more information on this trial, please visit
Plecanatide is Synergy’s lead guanylate cyclase-C (GC-C) agonist in
development to treat patients with chronic idiopathic constipation (CIC) and
irritable bowel syndrome with constipation (IBS-C). Plecanatide is a
16-amino-acid analog of the human gastrointestinal (GI) hormone, uroguanylin,
a natural agonist for the intestinal GC-C receptor. Orally administered
plecanatide mimics uroguanylin’s functions by binding to and activating the
GC-C receptor to stimulate fluid secretion and transit required for normal
digestion. Synergy has successfully completed a phase 2b trial of plecanatide
with CIC patients and is currently enrolling patients into its pivotal phase 3
CIC program. 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.
Synergy Pharmaceuticals Inc.
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