FDA OK’s Cerenis’s CER-209 clinical trial for liver disease treatment

U.S. Food and Drug Administration (FDA) has given green light to Cerenis Therapeutics to proceed with CER-209 clinical trial.

The company said that the Investigational New Drug application (IND) for CER-209 includes plans for a Phase I clinical study of its P2Y13 receptor agonist drug candidate (CER-209) in healthy volunteers for the clinical investigation of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steato-Hepatitis (NASH). Cerenis plans to begin enrollment in Q1 2017.

Dr. Jean-Louis Dasseux, CEO of Cerenis, comments, “The successful filing of our IND and approval by the FDA to proceed with our first Phase 1 clinical trial for CER-209 is a major strategic milestone for Cerenis. Our team has demonstrated how efficiently it can advance our drug candidates into the clinic, supported by its in-depth expertise of lipid metabolism, specifically regarding the reverse lipid transport mediated by the HDL particle. We believe CER-209 will be a compelling drug candidate for the treatment of NAFLD and NASH, through its ability to promote HDL recognition and lipid elimination by the liver, and overall reaffirmed the potential of our therapy approaches.”

“Incidences of NAFLD and NASH are increasing, becoming common diseases of the liver with the rise in obesity rates. NAFLD is a universal disorder that is now considered as the most common liver disease in the western world, impacting 30% of the world’s population, according to a publication in the World Journal of Hepatology. In addition, the American Liver Foundation says that NASH is one of the leading causes of cirrhosis in adults in the United States, with up to 25% of adults with NASH having cirrhosis. There currently are no approved therapies for these diseases and we are hopeful that CER-209 will be able to play a role in treatment,” Dr. Dasseux added.