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Conatus Pharmaceuticals begins Phase 2 clinical trials for fatty liver disease


Conatus Pharmaceuticals Inc. has announced the initiation of a Phase 2 clinical trial of its lead drug emricasan for the treatment of patients with chronic liver disease and acute exacerbations of chronic liver disease, including acute-on-chronic liver failure, chronic liver failure, Non-alcoholic fatty liver disease ( NAFLD) and non-alcoholic steathepatitis (NASH), as well as Post Orthotopic Liver Transplant recipients with reestablished liver fibrosis as a result of recurrent post-transplant hepatitis C virus infection who have “successfully achieved a sustained viral response following HCV antiviral therapy.

Emricasan is a first-in-class, orally active caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and cell death, or apoptosis. To date, emricasan has been administered to over 500 subjects in six Phase 1 and four Phase 2 clinical trials, and “ has also been extensively profiled in in-vitro tests and studied in many pre-clinical models of human disease.”

"Compelling preclinical data in models of both NAFLD and NASH suggest therapeutic potential for emricasan," said Conatus Co-founder, President and Chief Executive Officer, Steven J. Mento, Ph.D., "and we believe that this trial is an important first step to evaluate that potential. Our goal for this trial is to expand our safety database into a broader patient population and to explore emricasan's potential activity in the NAFLD/NASH population. Clinical endpoints suitable to support approval of new treatments for NASH have not yet been fully defined, and we are appropriately engaged in the ongoing discussions."

NAFLD which includes a spectrum of liver disease ranging from simple steatosis (fat deposition) to necrosis and inflammation characteristic of NASH has emerged as the most common form of liver disease in the US. Patients with NASH have an increased risk for disease progression to liver fibrosis and irreversible liver cirrhosis, and according to Mento, is the “3rd most common cause of liver transplantation in the United States.”

He also mentioned that Conatus is also supporting a pilot clinical study funded by the National Institute on Alcohol Abuse and Alcoholism in patients with severe alcoholic hepatitis.

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