Plecanatide Relieves Constipation without Diarrhea in Phase II Trial

Synergy Pharmaceuticals, Inc. announced positive results in a Phase IIa clinical trial of plecanatide in patients with chronic constipation.

The data will be presented on Monday, October 18, 2010 (Poster Number P762; 10:30am-4:00pm) at the American College of Gastroenterology Annual Scientific meeting in San Antonio, TX.

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 diarrhea. Additionally, no systemic absorption of plecanatide was detected in patients at any of the dose levels studied.

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.

"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," said Gary S. Jacob, Ph.D., President and CEO of Synergy.

Source: Synergy Pharmaceuticals