Synergy Pharma Initiates First Phase 3 Trial Of Plecanatide - Quick Facts

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP), Wednesday said it started the first of two planned phase 3 clinical trials of plecanatide, its lead GC-C agonist and once-daily oral treatment, in adult patients with chronic idiopathic constipation or CIC. The trial will confirm the safety and efficacy of the agonist.

The 12-week phase 3 trial, will be conducted at about 180 sites in the United States and Canada, in 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. The company said that Plecanatide already showed a favorable safety and efficacy profile in a recently completed large, multi-center study in 951 patients with CIC.