Synergy Pharma (SGYP) Will Present New Plecanatide Data in CIC, IBS-C at ACG Meeting

September 28, 2016 9:32 AM EDT
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Synergy Pharmaceuticals Inc. (Nasdq: SGYP) announced that the company will present new data on plecanatide, an investigational compound for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), at the American College of Gastroenterology (ACG) annual scientific meeting at The Venetian in Las Vegas, October 14-19, 2016.

The following two posters will be presented in Hall C on Monday, October 17th from 10:30 a.m.-4:00 p.m. PT with author presentation at the poster from 1:00-2:15 p.m. PT:

  • P1041A. Efficacy and Safety of Plecanatide in the Treatment of Chronic Idiopathic Constipation (CIC): Pooled Results from Two Phase 3 Studies*2016 ACG Presidential Poster Award

-- Presenter: Satish S.C. Rao, MD, PhD, Professor of Medicine, Division Chief Fellowship Program Director, Director Digestive Health Center

  • P1120. Safety and Tolerability of Plecanatide in Patients with Chronic Idiopathic Constipation: Long-term Evidence from an Open-Label Study

-- Presenter: Marianela De La Portilla, MD, Genome Research Group, Miami, FL

Plecanatide is a once-daily, orally-administered compound currently being evaluated by the U.S. Food and Drug Administration (FDA) for the treatment of CIC and the Prescription Drug User Fee Act (PDUFA) target action date for plecanatide is January 29, 2017.

In addition, Synergy has already completed patient recruitment for the two double-blind placebo-controlled phase 3 clinical trials with plecanatide in IBS-C and remains on-track to report top-line data from both trials in the fourth quarter of this year. Pending approval in the CIC indication, Synergy plans to file a New Drug Application Supplement with Clinical Data (sNDA) for plecanatide in IBS-C in the first quarter of 2017 and expects a 10-month review period from submission.

About Chronic Idiopathic Constipation (CIC)

CIC affects 14 percent of the population in North America, disproportionately affecting women and older adults. People with CIC have persistent symptoms of difficult and infrequent bowel movements. CIC can severely impact people’s daily lives, increasing stress levels and anxiety.

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