The Phase II double-blinded, randomized, placebo-controlled study will assess cobiprostone’s safety and efficacy in treating portal hypertension. The study plans to enroll approximately 30 patients at the University of Texas Southwestern Medical Center in Dallas.
The primary efficacy endpoint is the change from baseline in hepatic venous pressure gradient (HVPG) 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.
Sucampo’s cobiprostone is also in clinical development for the treatment of gastrointestinal ulcers in patients treated with prescription non-steroidal anti-inflammatory drug therapy. To date, cobiprostone has been evaluated in two Phase I trials in healthy volunteers, and in three Phase II proof-of-concept trials.
Ryuji Ueno, chairman and CEO of Sucampo, said: “Approximately one-third of deaths in patients with cirrhosis are caused by esophageal variceal bleeding due to portal hypertension. We believe that cobiprostone may lessen portal vein pressure and may reduce the likelihood of variceal bleeding.”