Synergy Pharmaceuticals, Inc. (OTC BB:SGYP), a developer of new drugs to treat gastrointestinal (GI) disorders and diseases, today announced that the next clinical trial of plecanatide to treat chronic idiopathic constipation patients, planned to begin in the second quarter of 2011, has been designed as a Phase II/III trial. The trial, a 90-day repeat oral dose ranging, randomized, double-blind, placebo-controlled study, will utilize approximately 800 chronic constipation patients, and will have as its primary objective the measure of complete spontaneous bowel movements (CSBM's) using a responder analysis. The trial will also evaluate spontaneous bowel movements (SBM's) and daily constipation symptoms including straining, stool consistency, abdominal discomfort, plus impact of plecanatide on disease specific quality of life measures.
Synergy recently announced positive results in a Phase IIa clinical trial of plecanatide in patients with chronic constipation. Oral plecanatide given once daily, over 14 consecutive days, at doses of 0.3, 1.0, 3.0 and 9.0 mg improved bowel function in patients with chronic constipation. Benefits were observed in increased frequency of bowel movements, decreased straining and abdominal discomfort, and improvement in other associated clinical measures. Plecanatide treatment exhibited an excellent safety profile. No severe adverse events were observed, and notably no patients receiving plecanatide reported drug-related diarrhea. Additionally, no systemic absorption of plecanatide was detected in patients at any of the dose levels studied.
"Based on recent discussions we have had with FDA plus our analysis of the overall results of our Phase IIa trial of plecanatide, we believe that plecanatide offers us a unique opportunity to accelerate the drug's development by designing the next clinical trial of plecanatide to meet the key endpoint for an approval in chronic constipation, namely, a CSBM responder analysis over a 90-day treatment period in chronic constipation patients," said Gary S. Jacob, President & CEO.
Synergy Pharmaceuticals, Inc.