Synergy Reports Results From Phase 2b Plecanatide Study - Quick Facts

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP) announced the results from a phase 2b dose-ranging study assessing plecanatide's safety and efficacy in 424 adult patients (mITT population= 423) with irritable bowel syndrome with constipation, IBS-C. The company said the data demonstrated that plecanatide, once-daily oral tablet, significantly improved complete spontaneous bowel movement frequency, bowel habits, treatment satisfaction and significantly reduced abdominal pain in patients with IBS-C throughout the 12 week treatment period. Patients taking 3.0 and 9.0 mg plecanatide showed statistically significant improvement in the Overall Responder rate, a secondary analysis in the study and the endpoint required for FDA approval in IBS-C.

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