Synergy Pharma Starts Second Pivotal Phase 3 Clinical Trial Of Plecanatide

(RTTNews) - Synergy Pharmaceuticals, Inc. (SGYP) Monday announced the start of its second pivotal phase 3 clinical trial to confirm the safety and efficacy of plecanatide, its lead uroguanylin analog and once-daily oral treatment, in adult patients with chronic idiopathic constipation or CIC.

This phase 3 trial is a randomized, double-blind clinical trial to compare a 12-week, dose-ranging regimen of plecanatide against placebo in adult patients with CIC.

The study will be conducted at about 180 sites in the U.S. and will enroll around 1350 patients with CIC.

The primary endpoint of the study is the proportion of patients who are overall responders for the 12-week treatment period.

This study will be running in parallel with the first phase 3 CIC trial that was initiated in November 2013. The phase 3 program will enroll approximately 2700 patients with CIC.