Sucampo enrolls first patient in Ph II cobiprostone trial

The USA's Sucampo Pharmaceuticals has enrolled the first patient in a single-center Phase II trial evaluating cobiprostone for portal hypertension in patients with liver cirrhosis.

The double-blinded, randomized, placebo-controlled study will assess the agent's safety and efficacy in treating portal hypertension. The trial plans to enroll approximately 30 patients at the USA's University of Texas Southwestern Medical Center in Dallas. The primary efficacy endpoint is the change from baseline in hepatic venous pressure gradient following 28 days of study treatment. Secondary endpoints include acute changes in HVPG following initial dosing with cobiprostone, as well as changes in other markers of liver disease and patient-reported quality of life measures.

Cobiprostone is a functional fatty acid and a member of a class of compounds called prostones. It is a locally-acting CIC-2 chloride channel activator that works on ion channels located in the liver and the gastrointestinal tract. In preclinical studies, the agent decreased portal vein pressure in a hepatic cirrhosis model and reduced vascular resistance in the liver in an ex vivo model.