Synergy Pharmaceuticals Announces Plans to Initiate a Phase 2 Study of SP-333 for Opioid-Induced Constipation

  Synergy Pharmaceuticals Announces Plans to Initiate a Phase 2 Study of
  SP-333 for Opioid-Induced Constipation

Business Wire

NEW YORK -- October 2, 2013

Synergy Pharmaceuticals Inc. (Nasdaq:SGYP) today announced plans to move
forward this quarter with SP-333, its proprietary next-generation guanylate
cyclase-C (GC-C) agonist, into a phase 2 study for the treatment of
opioid-induced constipation (OIC).

“The start of this trial represents the ongoing progress being made in the
clinical development of our novel GC-C agonist platform in multiple
gastrointestinal indications,” said Dr. Gary S. Jacob, President and Chief
Executive Officer of Synergy Pharmaceuticals Inc. “We recognize a significant
market opportunity for new OIC drug candidates and believe SP-333 has
excellent potential to address the unmet medical needs of these patients. We
look forward to evaluating the potential role of SP-333 for OIC as part of our
continuing commitment to deliver value to our shareholders and improve patient
care.”

The phase 2 trial is designed as a dose-ranging study to evaluate a 4-week
regimen of SP-333, a once daily oral treatment, in adult patients taking
opioid analgesics for chronic, non-cancer pain for at least three months. The
only oral drug currently FDA approved to treat OIC in patients with chronic,
non-cancer pain requires multiple daily dosing and it is not effective against
methadone-related OIC.

Pre-clinical data on SP-333 in an animal model of OIC will be featured in a
poster presentation at the American College of Gastroenterology (ACG) 2013
Annual Scientific Meeting being held October 11-16 in San Diego, California.

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 the phase 3
registration trial for plecanatide in CIC this quarter. 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 and inflammatory bowel disease. SP-333 has
completed a phase I study in healthy volunteers and will enter phase 2 trials
for OIC in the fourth quarter of 2013. 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:

Media Contact
Gem Gokmen
Office: 212-584-7610
Mobile: 646-637-3208
ggokmen@synergypharma.com
or
Investor Contact
Bernard Denoyer
Office: 212-297-0020
Mobile: 203-300-8147
bdenoyer@synergypharma.com
 
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