Phase 2a study of SP-304 for the treatment of chronic constipation (CC)

Synergy Pharmaceuticals announced the initiation of dosing in a Phase 2a clinical trial of SP-304 in patients with chronic constipation (CC). This trial is a randomized, double-blind, placebo-controlled, 14-day repeat, oral, dose-escalation study in patients with chronic constipation. The objectives of the trial are to characterize the safety of SP-304 for 14 days in patients with CC and establish doses for the larger planned Phase IIb trial in CC patients.

SP-304 is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Orally administered SP-304 binds to and activates guanylate cyclase C (GC-C) expressed on epithelial cells lining the GI mucosa, resulting in activation of the cystic fibrosis transmembrane conductance regulator (CFTR), and leading to augmented flow of chloride and water into the lumen of the gut, facilitating bowel movement. In animal models, oral administration of SP-304 promotes intestinal secretion as well as ameliorating gastrointestinal inflammation.

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