Synergy Pharmaceuticals Completes Phase I Trial of SP-333 to Treat Gastrointestinal Diseases

Synergy Pharmaceuticals

announced today the successful completion of a Phase I single-ascending-dose clinical trial of SP-333, a guanylate cyclase C (GC-C) agonist designed to treat ulcerative colitis (UC) and other GI diseases. SP-333 has exhibited potent anti-inflammatory activity in animal studies of colitis, displaying a novel mechanism-of-action that the Company believes can provide a new way to treat UC patients with mild to moderate disease.  This study was designed as a placebo-controlled, dose-escalating, single-dose trial in healthy adult volunteers, primarily focused on exploring the safety profile of SP-333. Eight cohorts were dosed, ranging from 0.1 to 60 mg of SP-333. There were no serious or unexpected adverse events in this study. Importantly, SP-333 exhibited gastrointestinal pharmacodynamic characteristics that were anticipated based on its GC-C receptor agonist activity.  A multi-dose, dose-escalation trial in volunteers is planned to start in January. "We specifically designed SP-333 to have superior stability against proteolytic degradation which normally occurs in intestinal fluid designed to break down proteins and peptides as part of the normal digestive process," said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy Pharmaceuticals. "SP-333, to our