[By NBC-1TV H. J Yook]Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal (GI) disorders, announced today that oral dosing of healthy volunteers has begun in a Phase I clinical trial of SP-333, a guanylate cyclase C (GC-C) agonist for the treatment of inflammatory bowel disease (IBD) including ulcerative colitis (UC). SP-333 has exhibited potent anti-inflammatory activity in animal studies of colitis, displaying a novel mechanism-of-action that the company believes could provide a new way to treat UC patients with mild-to-moderate disease.

“We‘re pleased with the results of our SP-333 single-dose-ascending trial in healthy volunteers, which was completed in late 2012, and are eager to move forward with further development of SP-333,” said Dr. Gary S. Jacob, President and CEO of Synergy Pharmaceuticals. “This second trial is an important step in ultimately evaluating SP-333’s potential to treat GI inflammatory diseases such as UC.”

The present trial, designed as a placebo-controlled, dose-escalating, multiple-dose study in 64 healthy adult volunteers, is focused on exploring the safety profile of SP-333. The study will take place in one site in the United States.

“SP-333 is our first clinical candidate for evaluating the anti-inflammatory potential of GC-C receptors to treat GI anti-inflammatory conditions such as UC,” said Dr. Kunwar Shailubhai, Synergy's Chief Scientific Officer. “In experimental models of colitis in mice, we have found that treatment with SP-333 ameliorates GI inflammation, likely through inhibition of NF-kappa B signaling to suppress production of pro-inflammatory cytokines.”