Synergy Pharmaceuticals, Inc. (OTC QB: SGYP), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced initiation of dosing of patients in a major Phase II/III clinical trial of plecanatide to treat chronic idiopathic constipation (CIC). This study is being conducted at 110 sites in the United States and is designed to enroll 880 patients with CIC who will be treated with one of three doses of plecanatide (0.3, 1.0 or 3.0 mg) or placebo taken once daily over a period of 12 weeks. Two CIC-study investigator meetings were recently held in Denver and New Orleans to prepare investigators for the multicenter trial, and Synergy is utilizing PAREXEL International as its Contract Research Organization for this study.
"The initiation of this trial represents a major milestone in our development of plecanatide to treat GI disorders, and the advancement of Synergy," said Gary S. Jacob, Ph.D., President and Chief Executive Officer of Synergy. "We believe plecanatide, which is an analog of the natural GI hormone uroguanylin, is capable of producing an ideal combination of efficacy and safety for patients with chronic idiopathic constipation, and has similar potential for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) as well."
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