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Synergy Pharmaceuticals Inc. (Nasdaq: SGYP), a developer of new drugs to treat gastrointestinal diseases and disorders, today announced that it has reached the halfway mark for total enrollment in its ongoing plecanatide Phase 2b clinical trial in patients with irritable bowel syndrome with constipation (IBS-C).
The study is being conducted at 70 sites in the United States and is scheduled to include 350 patients with IBS-C. Over 600 patients have been screened to date and 180 have been enrolled. The first patient was dosed on December 27, 2012 and Synergy anticipates completing enrollment in the fourth quarter of 2013 and reporting topline data in the first quarter of 2014.
The trial, entitled, “A randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation,” (
http://clinicaltrials.gov/ct2/show/NCT01722318?term=plecanatide&rank=2) includes four doses of plecanatide (0.3,1.0,3.0,9.0 mg) plus a placebo arm, taken once daily over a period of 12-weeks.
Plecanatide IBS-C Study Design
Patients must meet modified Rome III criteria for IBS-C as demonstrated by a history of recurrent abdominal pain or discomfort covering at least 3 days/month in the last 3 months associated with two or more of: 1) improvement with defecation, 2) onset associated with a change in frequency of stool, and 3) onset associated with a change in form (appearance) of stool. Patients must also meet the criteria for the IBS-C subtype, which is further characterized by stool pattern, such that ≥ 25% of defecations are hard or lump stools and ≤ 25% of defecations are loose or watery stools. During pre-treatment, baseline patients are required to have at least 3 days in each week with pain scores ≥ 3 on a 0 to 10 scale.
The IBS-C trial will measure the mean change in CSBMs over the 12-week treatment period relative to patient’s baseline weekly CSBM rate established during the screening phase of the study. The study will also evaluate spontaneous bowel movements (SBMs) and daily abdominal pain, discomfort and bloating scores as well as the impact of plecanatide on disease-specific quality of life measures.