Synergy reports more IBS-C data for plecanatide
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) said once-daily 3 mg oral plecanatide (formerly SP-304) met the primary endpoint of improving the mean number of complete spontaneous bowel movements from baseline over the 12-week treatment period vs. placebo in a Phase IIb trial to treat irritable bowel syndrome with constipation (IBS-C) (p<=0.001). Data for the other doses of plecanatide were not disclosed. The double-blind, U.S. trial enrolled 424 IBS-C patients.
Next half, Synergy plans to start placebo-controlled Phase III testing with the 3 mg dose to treat IBS-C. Plecanatide is also in two Phase III trials to treat chronic idiopathic constipation (CIC), with data from the first trial expected in 2Q15. Plecanatide is a guanylate cyclase C ( GCC; GUCY2C) agonist. Synergy was off $0.33 to $4.49 on Wednesday. ...