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October 22, 2012

Synergy begins dosing in Phase I trial of SP-333

Synergy Pharmaceuticals has begun oral dosing of healthy volunteers in a Phase I trial of SP-333, a synthetic analog of uroguanylin.

Synergy Pharmaceuticals has begun oral dosing of healthy volunteers in a Phase I trial of SP-333, a synthetic analog of uroguanylin.

SP-333 is a guanylate cyclase C (GC-C) agonist designed to treat ulcerative colitis (UC), a type of inflammatory bowel disease that causes chronic inflammation of the colon.

The candidate has displayed a new mechanism-of-action, exhibiting potent anti-inflammatory activity in animal studies of colitis.

Synergy Pharmaceuticals chief scientific officer Dr Kunwar Shailubhai said disruption of intestinal barrier function is one of the primary causes of the pathogenesis of inflammatory bowel diseases such as ulcerative colitis.

"Oral treatment with SP-333 to augment intestinal GC-C activation represents a novel approach for restoring mucosal barrier function and suppressing inflammation," Shailubhai said.

"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."

The placebo-controlled, dose-escalating, single-dose study is principally focused on exploring the safety profile of SP-333.

A multi-dose, dose-escalation trial is scheduled for early 2013.

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