Synergy Pharmaceuticals Initiates First Phase 3 Clinical Trial of
Plecanatide in Patients with Chronic Idiopathic Constipation
NEW YORK -- November 13, 2013
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the start of the
first of two planned phase 3 clinical trials to confirm the safety and
efficacy of plecanatide, its lead GC-C agonist and once-daily oral treatment,
in adult patients with chronic idiopathic constipation (CIC).
The pivotal 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 Canada 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
“Plecanatide has already demonstrated a favorable safety and efficacy profile
in a recently completed large, multi-center study in 951 patients with CIC,”
said Dr. Gary S. Jacob, Chief Executive Officer of Synergy Pharmaceuticals
Inc. “We look forward to further evaluating the effect of plecanatide in CIC
patients and believe it is well positioned to be the best-in-class GC-C
agonist with superior pharmacologic properties that support a very unique
About Chronic Idiopathic Constipation
Chronic constipation is the most common digestive complaint worldwide. About
15%, or 45 million people, suffer from chronic constipation in the U.S., with
a similar prevalence in other developed countries. Although chronic
constipation affects both men and women of every age, it disproportionately
impacts women as well as the elderly, a large and growing population.
Current treatments provide temporary relief, but because they fail to address
the underlying causes of chronic constipation, they do not normalize patients'
bowel function. Such treatments are also associated with unpleasant side
effects, the most common of which is diarrhea, causing patients to see-saw
between extremes. As a result, most doctors and their patients are
dissatisfied with current treatments for chronic constipation.
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 synthetic
analog of uroguanylin, a naturally occurring human GI hormone and
physiological agonist of the GC-C receptor. Orally administered plecanatide
mimics uroguanylin’s natural activity, binding to and activating the GC-C
receptor expressed in the GI tract, resulting in fluid secretion and
normalization of bowel movement. In early 2013, Synergy announced positive
results from a large multicenter trial of plecanatide in patients with CIC and
completed an end-of-phase 2 meeting with the U.S. Food and Drug Administration
(FDA) in July covering the registration program for plecanatide to treat CIC.
Synergy plans to announce topline data results from its ongoing phase 2b study
of plecanatide in IBS-C patients in 1Q2014.
About Synergy Pharmaceuticals Inc.
Synergy Pharmaceuticals is a biopharmaceutical company focused on the
development of new drugs to treat patients with gastrointestinal (GI) diseases
and disorders. Synergy’s second GC-C agonist, SP-333, is in clinical
development to treat opioid-induced constipation (OIC) and ulcerative colitis
(UC). SP-333 has successfully completed phase I single and multiple ascending
dose studies in healthy volunteers and is currently in a phase 2 clinical
trial for OIC. More information is available at 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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