Synergy Pharmaceuticals announced positive results in a Phase 2a clinical trial of plecanatide (SP-304) in patients with chronic constipation. This study was a randomized, double-blind, placebo-controlled, dose-escalation, cohort-design, multi-center clinical trial in 78 patients with chronic constipation. The trial utilized a modified Rome III criteria for enrollment and was designed primarily as a safety study, but with the inclusion of measures of bowel function and patient-reported symptoms to provide information on the pharmacodynamic effects of plecanatide on patients with chronic constipation.
Patients were monitored for number of spontaneous and complete-spontaneous bowel movements, stool consistency using the Bristol Stool Form Scale, and ease of stool passage, abdominal discomfort, constipation severity and overall relief. Oral plecanatide given once daily, over 14 consecutive days, at doses of 0.3, 1, 3 and 9mg gave improved bowel function in patients with chronic constipation. Benefits were observed in increased frequency of bowel movements, decreased straining and abdominal discomfort, and improvement in other associated clinical measures.
Plecanatide is a non-systemic, synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract. Plecanatide 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.
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