Synergy Pharmaceuticals Initiates Second Phase 3 Clinical Trial of
Plecanatide in Patients with Chronic Idiopathic Constipation
NEW YORK -- April 28, 2014
Synergy Pharmaceuticals Inc. (NASDAQ: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,
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
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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