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.”
Clinical Trial Design
Synergy’s Phase II/III trial of plecanatide to treat CIC patients (SP304-20210) is entitled: “A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients with Chronic Idiopathic Constipation.” This study is being conducted at 110 sites in the United States, and is designed to enroll 880 patients with CIC who will be randomized evenly to one of three doses of plecanatide (0.3, 1.0 or 3.0 mg) or placebo taken once daily for 12 weeks. The study will have as its primary objective the measure of complete spontaneous bowel movements (CSBMs) using a responder analysis. The trial will also evaluate spontaneous bowel movements (SBMs) and daily constipation symptoms, as well as the impact of plecanatide on disease-specific quality of life measures. For further information on the trial please visit www.cicstudy.com or the ClinicalTrials.gov listing ( http://clinicaltrials.gov/ct2/show/NCT01429987?term=plecanatide&rank=1).About Plecanatide Plecanatide is a member of a new class of essentially non-systemic drugs, referred to as guanylate cyclase C (GC-C) agonists, that are currently in development to treat CIC and IBS-C, which includes a first-in-class drug being developed by Ironwood (Nasdaq: IRWD) and Forest Labs (NYSE: FRX). Plecanatide is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally-administered plecanatide binds to and activates GC-C receptors expressed on epithelial cells lining the GI mucosa, resulting in activation of the cystic fibrosis transmembrane conductance regulator (CFTR), and leading to augmented flow of chloride and water into the lumen of the gut. Activation of the GC-C receptor pathway is believed to facilitate bowel movement as well as producing other beneficial physiological responses including improvement in abdominal pain and inflammation. In animal models, oral administration of plecanatide promotes intestinal secretion and also ameliorates GI inflammation.