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Synergy (SGYP) Hits Halfway Enrollment Milestone in Plecanatide Phase II/III

April 9, 2012 7:16 AM EDT
Synergy Pharmaceuticals, Inc. (Nasdaq: SGYP) (Nasdaq: SGYPU) (Nasdaq: SGYPW), has successfully achieved the halfway mark for total enrollment in its ongoing plecanatide Phase II/III clinical trial in chronic idiopathic constipation (CIC) patients. Over 800 patients have been screened at present, resulting in a total of 440 randomized, enrolled patients to date. The trial, designed to enroll 880 patients to achieve 800 evaluable patients, was initiated on October 24, 2011. The Company anticipates completing enrollment of the trial in the third quarter of this year and reporting top line data in the fourth quarter.

The plecanatide CIC trial, entitled "A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Chronic Idiopathic Constipation - Protocol SP304-20210," includes 3 doses of plecanatide (0.3, 1.0, 3.0 mg) plus a placebo arm. Synergy developed a novel patient reported outcome (PRO) questionnaire for CIC symptoms that is being validated in this study. The primary endpoint is a responder analysis based on improvement in the number of complete spontaneous bowel movements in 9 of the 12 weeks of the treatment period. A nationwide advertising campaign has been launched for this study, with patients directed to the following website www.cicstudy.com or to a call center (1-855-CIC-9200).

Synergy also plans to commence a plecanatide Phase II clinical trial in constipation-predominant irritable bowel syndrome (IBS-C) patients in the second half of 2012. The study is planned to be conducted at 40 U.S. sites and to enroll over 300 patients. The protocol is aligned with the FDA guidance on Clinical Evaluation of Products for the Treatment of IBS-C issued in March, 2010. This will be the first study of plecanatide in this patient population.


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