Biopharmaceutical company Synergy Pharmaceuticals Inc. has completed an End-of-Phase II meeting with the US Food and Drug Administration (FDA) on its drug plecanatide for the treatment of chronic idiopathic constipation (CIC). At that meeting, agreement was reached on the clinical development plan.

A pivotal phase III programme evaluating the safety and efficacy of plecanatide in CIC patients will be initiated in the fourth quarter of 2013.

The agreement was reached with the FDA on design, duration, size and primary and secondary efficacy endpoints for the pivotal phase III studies.

"We are very pleased with the outcome of our end-of-phase II meeting with the FDA where clear guidance was provided on clinical safety and efficacy requirements for completion of a registration programme 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 III development programme, and we are now focused on the initiation of pivotal studies in the fourth quarter of this year."

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.

Synergy Pharmaceuticals Inc. is a biopharmaceutical company focused on the development of new drugs to treat patients with gastrointestinal (GI) diseases and disorders.