Synergy 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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