Synergy Pharmaceuticals Closes Enrollment for Phase 2b Plecanatide Trial in Patients with IBS-C
Synergy Pharmaceuticals. (NASDAQ: SGYP) today announced it has closed
patient enrollment in its plecanatide phase 2b clinical trial in
irritable bowel syndrome with constipation (IBS-C).
The clinical trial is being conducted at approximately 70 sites in the
United States and includes four doses of plecanatide (0.3mg, 1.0mg,
3.0mg, 9.0mg) plus a placebo arm, taken once daily over a period of 12
weeks. The primary endpoint is change from baseline in the mean number
of complete spontaneous bowel movement (CSBM) over the 12 week treatment
period. The first patient was dosed on December 27, 2012 and Synergy
anticipates reporting topline data in the beginning of the second
quarter of 2014.