Synergy's Phase 2b Study In IBS-C Patients Achieves Primary Endpoint

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP) Wednesday said its Phase 2b study of plecanatide achieved primary endpoint of statistically significant improvement in complete spontaneous bowel movement or CSBM in patients with irritable bowel syndrome with constipation or IBS-C. The Phase 2b trial studied the safety and efficacy of plecanatide in 424 patients with IBS-C.

Irritable bowel syndrome is a common gut disorder that can cause bouts of stomach cramps, bloating, diarrhoea and constipation. The cause of the condition is unknown.

During the trial, patients who took plecanatide 3.0 mg dose reported statistically significant improvement in change from baseline versus placebo in worst abdominal pain and met the FDA overall responder endpoint for IBS-C over the 12-week treatment.

Synergy expects to move forward with the 3 mg dose and plans to initiate Phase 3 trials in the second half of this year.