Synergy Pharma Reaches Halfway Mark For Second Phase 3 Trial Of Plecanatide

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP) announced that it has reached the halfway mark for total enrollment in the second pivotal phase 3 trial of plecanatide in patients with chronic idiopathic constipation or CIC.

The trial is currently being conducted at 180 sites and has randomized over 675 CIC patients. This is the second of two ongoing phase 3 pivotal trials designed to confirm the efficacy and safety of both 3.0 mg and 6.0 mg plecanatide once-daily oral tablet versus placebo in patients with CIC. Synergy announced it had achieved the halfway mark for total enrollment in the first phase 3 CIC trial in July 2014.

The company noted that it plans to release top-line data from the first phase 3 CIC trial in the second quarter of 2015 and top-line data from the second study in the third quarter of 2015.

Plecanatide is Synergy's lead uroguanylin analog in late-stage clinical development to treat patients with CIC and irritable bowel syndrome with constipation (IBS-C). Uroguanylin is a natural gastrointestinal (GI) hormone produced by humans in the small intestine and plays a key role in regulating the normal functioning of the digestive tract through its activity on the guanylate cyclase-C (GC-C) receptor. The GC-C receptor is known to be a primary source for stimulating a variety of beneficial physiological responses.

Orally administered plecanatide mimics uroguanylin's functions by binding to and activating the GC-C receptor to stimulate fluid and ion transit required for normal bowel function.

Synergy has successfully completed a phase 2b trial of plecanatide in 951 patients with CIC and is currently enrolling patients in two pivotal phase 3 CIC trials. The company also recently announced positive top-line data results from a phase 2b dose-ranging study with plecanatide in patients with IBS-C.

Synergy plans to initiate the pivotal phase 3 IBS-C program in the fourth quarter of 2014.