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

NEW YORK--(BUSINESS WIRE)--

Synergy Pharmaceuticals Inc. 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.