A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis

Exclusion Criteria

• •Laboratory Screening Results:
• •* AST \>5 x ULN
• •* ALT \>5 x ULN
• •* Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels
• •* Total white blood cells (WBC) \<3000 cells/mm3
• •* Absolute neutrophil count (ANC) \<1500 cells/mm3
• •* Platelet count \<140,000/mm3
• •* Prothrombin time (international normalized ratio, INR) \>1.2
• •* Serum creatinine \>2 mg/dL or creatinine clearance \<60 mL/min (based on Cockroft-Gault Method)
• •Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening
• •Use of immunosuppressants known to have an effect on the liver of patients with PBC (eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months preceding screening
• •Current use of fibrates, including fenofibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate
• •Use of an experimental treatment for PBC within the past 6 months
• •Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers
• •Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma
• •Hepatorenal syndrome (type I or II) or Screening serum creatinine \> 2 mg/dL (178 μmol/L)
• •Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)
• •Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)
• •Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least 3 months prior to Screening are allowed. No dose modification during the study will be allowed.
• •Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive weeks in duration within 1 year prior to Screening.