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December 27, 2012
05:11 EDTPRXL, SGYPSynergy Pharmaceuticals begins Phase IIb trial of Plescanatide in IBS-C
Synergy Pharmaceuticals (SGYP) announced that dosing has commenced in a Phase IIb clinical trial of plecanatide to treat patients with constipation-predominant irritable bowel syndrome, or IBS-C. This trial is being conducted at 70 sites in the U.S. and includes 350 patients with IBS-C who will be treated with one of four doses of plecanatide or placebo, taken once daily over a period of 12 weeks. PAREXEL International (PRXL) is the Contract Research Organization for the trial.
News For SGYP;PRXL From The Last 14 Days
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December 18, 2014
06:15 EDTSGYPSynergy Pharmaceuticals initiates Phase 3 trial for irritable bowel syndrome
Synergy Pharmaceuticals Inc. initiated the first of two planned pivotal phase 3 clinical trials evaluating the safety and efficacy of 3.0 and 6.0 mg plecanatide, once-daily oral tablets, for the treatment of irritable bowel syndrome with constipation. Synergy is also evaluating 3.0 and 6.0 mg doses of plecanatide in two ongoing pivotal phase 3 trials for chronic idiopathic constipation, scheduled to read out top-line results in Q2 and Q3 2015. The pivotal phase 3 trial is expected to enroll approximately 1050 adult patients with IBS-C. The primary efficacy endpoint for this trial is the percentage of patients who are Overall Responders during the 12 week treatment period. Synergy plans to initiate the second pivotal phase 3 IBS-C trial with plecanatide in 1H15.

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