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.