Today, Synergy Pharmaceuticals announced that it will make a poster presentation on SP-333, its next-generation guanylate cyclase-C (GC-C) agonist for treating ulcerative colitis, at the 2012 Advances in Inflammatory Bowel Diseases, Crohn's & Colitis Foundation's Clinical & Research Conference, Dec. 13-15 at the Westin Diplomat in Hollywood, Fla.
The poster depicts animal studies that show oral treatment with SP-333, an analog of uroguanylin, ameliorated gastrointestinal (NYSE:GI) inflammation in dextran sodium sulfate-induced colitis in mice, and also that down-regulation of NF-kB and pro-inflammatory cytokines was associated with administration of SP-333. Additionally, the data demonstrates that systemic absorption is minimal with orally administered SP-333 and is also unaffected by the severity of the experimental colitis. Recently, Synergy completed a single-dose, dose-escalating Phase I trial of SP-333 in healthy adult volunteers, and early next year the company is planning to initiate a multi-dose, dose-escalation study in healthy volunteers.
It is suggested by recent studies that expression of uroguanylin, the native GC-C agonist expressed in the human GI tract, is down-regulated in inflamed tissue from patients with Crohn's disease and also in patients with ulcerative colitis, which implies that uroguanylin deficiency may be associated with disruption of intestinal barrier function, one of the primary hypothesized causes of the pathogenesis of inflammatory bowel disease.
Treating orally with SP-333 to augment intestinal GC-C activation potentially represents a novel approach to restoring mucosal barrier function and suppressing inflammation. Experimental models of colitis in mice showed that treatment with SP-333 ameliorates GI inflammation, possibly through the inhibition of NF-kappa B signaling to suppress production of pro-inflammatory cytokines.
Synergy is a biopharmaceutical company focused on the development of new drugs to treat gastrointestinal disorders and diseases. Synergy's lead proprietary drug candidate, plecanatide, is a synthetic analog of the human gastrointestinal hormone uroguanylin and functions by activating the guanylate cyclase C receptor on epithelial cells of the GI tract. Synergy completed a Phase I study of plecanatide in healthy volunteers and a Phase IIa clinical trial in chronic idiopathic constipation (CIC) patients. In August of 2012, Synergy completed enrollment of patients in a major Phase II/III clinical trial of plecanatide to treat CIC. Plecanatide is also being developed to treat irritable bowel syndrome with constipation (IBS-C), with the first trial in IBS-C patients initiated in the second half of 2012. Synergy's second GC-C agonist SP-333 is in clinical development to treat inflammatory bowel diseases, and is presently in a Phase I trial in healthy volunteers.
For more information, visit www.synergypharma.com
Please see disclaimer on the MissionIR website http://www.missionir.com/disclaimer.html