Synergy Pharmaceuticals Initiates Phase 2 Study of SP-333 in Patients with Opioid-Induced Constipation

  Synergy Pharmaceuticals Initiates Phase 2 Study of SP-333 in Patients with
  Opioid-Induced Constipation

Business Wire

NEW YORK -- October 31, 2013

Synergy Pharmaceuticals Inc. (Nasdaq:SGYP) today announced the start of a
phase 2 clinical trial to evaluate the safety and efficacy of SP-333, its
second-generation GC-C agonist and once-daily oral treatment, in adult
patients with opioid-induced constipation (OIC).

The multi-center, randomized, double-blind clinical trial will compare a
4-week, dose-ranging regimen of SP-333 (1.0, 3.0 and 6.0mg) against placebo in
adult patients taking opioid analgesics for chronic, non-cancer pain for at
least three months. The study plans to enroll approximately 260 patients with
OIC who have less than 3 spontaneous bowel movements (SBMs) per week and who
experience constipation-related symptoms. The primary endpoint of the study is
mean change from baseline in the number of SBMs during Week 4 of the Treatment
Period.

“Orally administered SP-333 has exhibited compelling data in preclinical
models, demonstrating the ability to restore GI transit to normal levels and
alleviate the onset of opioid-induced bowel dysfunction,” said Dr. Kunwar
Shailubhai, Chief Scientific Officer, Synergy Pharmaceuticals Inc. “We are
particularly excited with preclinical data that indicates SP-333 may be
effective in treating methadone and morphine related constipation. Clinical
validation of efficacy in methadone-induced constipation would be a
breakthrough.”

“SP-333 marks Synergy’s second GC-C agonist in clinical development and
represents another important milestone achieved this year in advancing our
novel GC-C platform,” said Dr. Gary S. Jacob, Chief Executive Officer of
Synergy Pharmaceuticals Inc. “Given SP-333’s favorable profile, we believe it
has excellent potential to address the unmet needs of OIC patients. Beyond the
OIC opportunity, we are continuing to develop a formulation of SP-333 to
further explore its anti-inflammatory effect in patients with ulcerative
colitis. We believe SP-333 is a very unique GC-C agonist with multiple
pathways forward, expanding our ability to reach a broader market of patients
in a variety of GI areas.”

About Opioid-Induced Constipation

Opioid-induced constipation (OIC) is a common condition affecting patients who
receive opioid treatments to relieve pain. An estimated 12 million Americans
are currently taking chronic opioids and over 90% experience some form of
diminished bowel frequency. OIC is characterized by infrequent and incomplete
evacuation of stool, hard stool consistency and straining associated with
bowel movements. There is only one oral drug approved in the US to treat OIC
but it is not approved for use in methadone-induced constipation.

About SP-333

SP-333 is Synergy’s second-generation GC-C agonist in development to treat
patients with opioid-induced constipation (OIC) and ulcerative colitis (UC).
SP-333 is a synthetic analog of the naturally occurring gastrointestinal
hormone, uroguanylin, designed as a highly stable and potent peptide that is
resistant to proteolysis in gastric and intestinal fluids. 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.
Synergy is also developing a unique formulation of SP-333 for treating GI
inflammation in patients with UC. For more information, please visit
www.synergypharma.com.

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 lead proprietary drug candidate, plecanatide, is a
synthetic analog of the human GI hormone, uroguanylin, and functions by
activating the guanylate cyclase-C (GC-C) receptor on epithelial cells of the
GI tract. In early 2013, Synergy announced positive results from a large
multicenter trial of plecanatide in patients with chronic idiopathic
constipation (CIC) and recently completed an end-of-phase 2 meeting with the
U.S. Food and Drug Administration (FDA) covering the registration program for
plecanatide to treat CIC. The company plans to initiate a phase 3 registration
trial for plecanatide in CIC in 4Q2013. Synergy is also developing plecanatide
for the treatment of irritable bowel syndrome with constipation (IBS-C),
recently announcing that it had reached the halfway mark for total enrollment
in a plecanatide phase 2b clinical trial in patients with IBS-C. 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.

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, 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.

Contact:

Synergy Pharmaceuticals Inc.
Media
Gem Gokmen, Office: 212-584-7610
Mobile: 646-637-3208
ggokmen@synergypharma.com
or
Investors
Bernard Denoyer, Office: 212-297-0020
Mobile: 203-300-8147
bdenoyer@synergypharma.com
 
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