Published on July 20, 2012 at 1:13 AM
The trial will be conducted in two sequential pilot study groups of six patients each with two different dosages of emricasan for 14 days. Once optimal dosing has been determined from these pilot studies, the next proposed study would be a randomized, placebo-controlled study to explore the safety and efficacy of emricasan combined with other islet transplant treatment medications.
Emricasan is a novel small molecule inhibitor of activated caspases. Caspases are enzymes responsible for executing apoptotic pathways, or programmed cell death and are also involved in processing cytokines involved in inflammation. Conatus is planning Phase 3 clinical trials early next year to test emricasan as a treatment in patients for acute liver failure with underlying cirrhosis, and in patients with liver fibrosis. Emricasan has shown specificity in assays measuring caspase inhibition, and reduced apoptosis in a variety of cellular assays. It also demonstrated efficacy in a number of preclinical models of liver disease and islet transplantation as well as in models of damage to other organ systems. Positive Phase 2 data in a 12-week study in patients with chronic Hepatitis C virus (HCV) infection have indicated that the oral formulation of emricasan was well tolerated, and significantly improved key markers of liver damage as early as 7 days after initiation of therapy.
SOURCE Conatus Pharmaceuticals Inc.