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Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the start of the first of two planned phase 3 clinical trials to confirm the safety and efficacy of plecanatide, its lead GC-C agonist and once-daily oral treatment, in adult patients with chronic idiopathic constipation (CIC).
The pivotal phase 3 trial is a randomized, double-blind, clinical trial to compare a 12-week, dose-ranging regimen of plecanatide (3.0 and 6.0mg) against placebo in adult patients with CIC. The study will be conducted at approximately 180 sites in the United States and Canada and will enroll approximately 1350 patients with CIC. The primary endpoint of the study is the proportion of patients who are overall responders for the 12-week treatment period.
“Plecanatide has already demonstrated a favorable safety and efficacy profile in a recently completed large, multi-center study in 951 patients with CIC,” said Dr. Gary S. Jacob, Chief Executive Officer of Synergy Pharmaceuticals Inc. “We look forward to further evaluating the effect of plecanatide in CIC patients and believe it is well positioned to be the best-in-class GC-C agonist with superior pharmacologic properties that support a very unique tolerability profile.”
About Chronic Idiopathic Constipation
Chronic constipation is the most common digestive complaint worldwide. About 15%, or 45 million people, suffer from chronic constipation in the U.S., with a similar prevalence in other developed countries. Although chronic constipation affects both men and women of every age, it disproportionately impacts women as well as the elderly, a large and growing population.
Current treatments provide temporary relief, but because they fail to address the underlying causes of chronic constipation, they do not normalize patients' bowel function. Such treatments are also associated with unpleasant side effects, the most common of which is diarrhea, causing patients to see-saw between extremes. As a result, most doctors and their patients are dissatisfied with current treatments for chronic constipation.