Synergy Pharmaceuticals Inc. (SGYP) recently initiated a phase Ib study on its inflammatory bowel disease (IBD) candidate, SP-333. SP-333, a guanylate cyclase C (GC-C) agonist, is being developed for the treatment of IBD including ulcerative colitis (UC). Synergy Pharma expects to enroll 64 healthy adult volunteers for the phase I study. Synergy Pharma will be evaluating the safety profile of SP-333 in the placebo-controlled, dose-escalating, multiple-dose study.
In Dec 2012, the company completed a phase I single-ascending-dose clinical study on SP-333. SP-333 displayed potent anti-inflammatory activity in animal studies of colitis. The candidate showed a novel mechanism-of-action during the study, which could bring a new dimension to the treatment of mild-to-moderate UC.
The company mentioned in its press release that more than a half million people in the US live with UC.
Synergy Pharma primarily develops drugs for the treatment of gastrointestinal (GI) disorders and diseases. The company's lead candidate, plecanatide, is being developed for GI disorders.
The company is developing plecanatide for the treatment of constipation-predominant irritable bowel syndrome (IBS-C). The company initiated a phase IIb study in IBS-C patients last month. Currently the GI inflammatory disease market has companies like AstraZeneca (AZN).
Synergy Pharma was in the news recently as its stockholders approved Synergy Pharma's merger with Callisto Pharmaceuticals Inc. The merger between the companies closed on Jan 17, 2013.