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April 30, 2014
06:10 EDTSGYPSynergy Pharmaceuticals' plecanatide shows positive results in Phase 2B study
Synergy Pharmaceuticals announced positive top-line results from a phase 2b dose-ranging study assessing plecanatide’s safety and efficacy in 424 patients with irritable bowel syndrome with constipation. The primary objective of this trial was to determine an effective, safe and well tolerated dose for plecanatide phase 3 trials with IBS-C patients. Plecanatide demonstrated statistically significant improvement in complete spontaneous bowel movement frequency – the study’s primary endpoint – and was safe and well tolerated. The most common event was diarrhea, which occurred in 9.3% of the 3.0mg plecanatide-treated patients. The company intends to initiate pivotal phase 3 trials in IBS-C patients in 2H14.
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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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