- On July 17, 2013, Synergy reached the halfway mark for total enrollment in its plecanatide Phase 2b clinical trial in patients with IBS-C. At present, over 726 patients have been screened, and 204 patients have been enrolled in the study. Synergy anticipates completing enrollment in the fourth quarter of 2013 and reporting top line data in the first quarter of 2014.
- On August 5, 2013, Synergy completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding Synergy’s drug plecanatide for the treatment of chronic idiopathic constipation (CIC). Agreement was reached with the FDA on design, duration, size and primary and secondary efficacy endpoints for pivotal phase 3 studies. A pivotal phase 3 program evaluating the safety and efficacy of plecanatide in CIC patients and is expected to be initiated in the fourth quarter of 2013.
Synergy Pharmaceuticals Reports Second Quarter 2013 Financial Results
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