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Topline Data Show That Plecanatide Met Primary and Key Secondary Endpoints
NEW YORK, Jan. 2, 2013 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP) today announced that plecanatide, its investigational oral drug for the treatment of chronic idiopathic constipation (CIC), was well tolerated and met the primary and key secondary endpoints of a Phase IIb/III clinical study. Full study results will be presented at a major scientific meeting this year.
The randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging study was designed to determine whether plecanatide could increase the number of complete spontaneous bowel movements (CSBM's) and impact other parameters such as stool consistency, straining and time to first bowel movement in patients with CIC. The 12-week study, which included 951 CIC patients at 113 clinical sites in the United States, evaluated 3 doses of plecanatide (0.3, 1.0, 3.0 mg) plus a placebo arm.
Evidence of increasing efficacy was seen at increasing dose levels. Notably, the 3 mg dose in the current trial demonstrated a 19% (p=0.009) overall responder rate (vs. placebo of 10.7%), as well as demonstrating a mean increase in CSBMs over the 12-week treatment period of 2.13 (p<0.001). In addition, statistically significant improvements were seen in key secondary endpoints. The incidence of diarrhea at 3 mg was observed to be 9.7% (vs. placebo incidence of 1.3%).
"We look forward to presenting the full results of this clinical study, which confirmed the efficacy and safety of plecanatide," said Dr. Gary S. Jacob, President and CEO of Synergy Pharmaceuticals. "This trial also represents a major milestone for Synergy. We pioneered the study of analogs of the human hormone uroguanylin to treat gastrointestinal disorders in an effort to identify an agent that would normalize bowel movements with minimal diarrhea."
"Based on the results of this trial, we are convinced that plecanatide has the potential to be a safe, effective and much-needed new treatment for millions of patients who are living with chronic constipation," Dr. Jacob added.