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Novel therapeutic approach to be evaluated for its ability to reduce elevated bile acid levels and associated severe itching

SAN DIEGO – October 29, 2013 – Lumena Pharmaceuticals, a company developing oral therapeutics for rare liver diseases, today announced the dosing of the first patient in the CLARITY Phase II study of its drug candidate LUM001 in patients with primary biliary cirrhosis (PBC). LUM001 is being developed as a possible therapy for a number of cholestatic liver diseases including, PBC, Alagille syndrome, progressive familial intrahepatic cholestasis and primary sclerosing cholangitis, that result in impaired bile acid flow and retention of bile acids in the liver, leading to progressive liver damage and, ultimately, liver failure. In the CLARITY Phase II study, LUM001 is being evaluated for its ability to alleviate the symptom of severe itching associated with PBC.