Synergy reports positive results from plecanatide Phase IIa clinical trial for chronic constipation

Synergy Pharmaceuticals, Inc. (OTCBB: SGYP), a developer of new drugs to treat gastrointestinal disorders and diseases, announced today positive results in a Phase IIa clinical trial of plecanatide (SP-304) 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 gave 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 diarrhea. Additionally, no systemic absorption of plecanatide was detected in patients at any of the dose levels studied. The clinical data will be presented on Monday, October 18, 2010 (Poster Number P762; 10:30 AM to 4:00 PM) at the American College of Gastroenterology Annual Scientific meeting in San Antonio, Texas. Plecanatide is a member of a new class of non-systemic drugs, referred to as GC-C receptor agonists, for treatment of chronic constipation, irritable bowel syndrome with constipation (IBS-C) and other GI diseases.

“Millions of patients worldwide suffer from chronic constipation and other human GI conditions for which there are limited treatment options currently available.”

"We are very pleased with the superb safety profile that plecanatide exhibited in this trial," said Gary S. Jacob, Ph.D., President and CEO of Synergy. "Along with the clear trend in improvement of bowel function in patients treated with plecanatide compared to placebo, there was a complete absence of reported diarrhea, which bodes well for our plan to initiate a 450 patient, dose-ranging Phase IIb trial in chronic constipation in December, 2010, and our Phase II program in IBS-C in 2011."

"The successful completion of this Phase IIa trial represents a major milestone in the development of plecanatide to treat GI disorders," said Mr. Gabriele Cerrone, Chairman of Synergy. "Millions of patients worldwide suffer from chronic constipation and other human GI conditions for which there are limited treatment options currently available."