Phase 3 Pivotal Program to be Initiated in the Fourth Quarter of 2013
NEW YORK, NY, USA I August 5, 2013 I Synergy Pharmaceuticals Inc. (SGYP) today announced that it has completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on Synergy’s drug plecanatide for the treatment of chronic idiopathic constipation (CIC). At that meeting, agreement was reached on the clinical development plan. A pivotal phase 3 program evaluating the safety and efficacy of plecanatide in CIC patients will be initiated in the fourth quarter of 2013.
Agreement was reached with the FDA on design, duration, size and primary and secondary efficacy endpoints for the pivotal phase 3 studies.
“We are very pleased with the outcome of our end-of-phase 2 meeting with the FDA where clear guidance was provided on clinical safety and efficacy requirements for completion of a registration program for plecanatide in CIC,” said Dr. Gary S. Jacob, President and CEO of Synergy. “A great deal of effort and planning have gone into preparations for our phase 3 development program, and we are now focused on the initiation of pivotal studies in the fourth quarter of this year.”
About Plecanatide
Plecanatide is Synergy’s lead guanylate cyclase-C (“GC-C”) agonist in development to treat patients with the functional GI disorders of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a proprietary synthetic analog of uroguanylin, a hormone the body naturally produces to regulate critical GI functions. Orally administered plecanatide, like uroguanylin, binds to and activates the GC-C receptor expressed in the GI tract, resulting in fluid secretion and normalization of bowel movement.
About Synergy Pharmaceuticals, Inc.
Synergy Pharmaceuticals Inc. is a biopharmaceutical company focused on the development of new drugs to treat patients with gastrointestinal (GI) diseases and disorders. Synergy’s lead drug, plecanatide, and next generation candidate, SP-333, are proprietary analogs of the natural human GI hormone, uroguanylin, and members of the new class of guanylate cyclase-C (“GC-C”) agonists. Plecanatide is currently in development for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Synergy is currently enrolling IBS-C patients for its Phase 2b clinical trial. SP-333 is in development to treat patients with inflammatory bowel disease and other GI conditions. More information is available at www.synergypharma.com
SOURCE: Synergy Pharmaceuticals
Post Views: 218
Phase 3 Pivotal Program to be Initiated in the Fourth Quarter of 2013
NEW YORK, NY, USA I August 5, 2013 I Synergy Pharmaceuticals Inc. (SGYP) today announced that it has completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on Synergy’s drug plecanatide for the treatment of chronic idiopathic constipation (CIC). At that meeting, agreement was reached on the clinical development plan. A pivotal phase 3 program evaluating the safety and efficacy of plecanatide in CIC patients will be initiated in the fourth quarter of 2013.
Agreement was reached with the FDA on design, duration, size and primary and secondary efficacy endpoints for the pivotal phase 3 studies.
“We are very pleased with the outcome of our end-of-phase 2 meeting with the FDA where clear guidance was provided on clinical safety and efficacy requirements for completion of a registration program for plecanatide in CIC,” said Dr. Gary S. Jacob, President and CEO of Synergy. “A great deal of effort and planning have gone into preparations for our phase 3 development program, and we are now focused on the initiation of pivotal studies in the fourth quarter of this year.”
About Plecanatide
Plecanatide is Synergy’s lead guanylate cyclase-C (“GC-C”) agonist in development to treat patients with the functional GI disorders of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a proprietary synthetic analog of uroguanylin, a hormone the body naturally produces to regulate critical GI functions. Orally administered plecanatide, like uroguanylin, binds to and activates the GC-C receptor expressed in the GI tract, resulting in fluid secretion and normalization of bowel movement.
About Synergy Pharmaceuticals, Inc.
Synergy Pharmaceuticals Inc. is a biopharmaceutical company focused on the development of new drugs to treat patients with gastrointestinal (GI) diseases and disorders. Synergy’s lead drug, plecanatide, and next generation candidate, SP-333, are proprietary analogs of the natural human GI hormone, uroguanylin, and members of the new class of guanylate cyclase-C (“GC-C”) agonists. Plecanatide is currently in development for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Synergy is currently enrolling IBS-C patients for its Phase 2b clinical trial. SP-333 is in development to treat patients with inflammatory bowel disease and other GI conditions. More information is available at www.synergypharma.com
SOURCE: Synergy Pharmaceuticals
Post Views: 218
