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April 28, 2014
06:09 EDTSGYPSynergy Pharmaceuticals to start second phase 3 clinical trial for plecanatide
Synergy Pharmaceuticals announced the start of its second pivotal phase 3 clinical trial to confirm the safety and efficacy of plecanatide, its lead uroguanylin analog and once-daily oral treatment, in adult patients with chronic idiopathic constipation, or CIC. This phase 3 trial is a randomized, double-blind clinical trial to compare a 12-week, dose-ranging regimen of plecanatide against placebo in adult patients with CIC.
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October 21, 2014
06:06 EDTSGYPSynergy Pharm' presents positive data from phase 2b study of plecanatide
Synergy Pharmaceuticals announced the presentation of results from a phase 2b dose-ranging study assessing plecanatide’s safety and efficacy in 424 adult patients with irritable bowel syndrome with constipation. Data presented at ACG demonstrate 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. Notably, patients taking 3.0 and 9.0 mg plecanatide showed statistically significant improvement in the Overall Responder rate, a secondary analysis in this study and the endpoint required for FDA approval in IBS-C.

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