Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Exclusion Criteria

• •1. Ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.
• •2. Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular carcinoma.
• •3. Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.
• •4. Weight loss of \>5% within 3 months prior to Baseline.
• •5. History of bariatric surgery within 5 years of Screening.
• •6. Diabetes mellitus other than Type II.
• •7. Hemoglobin A1c \>9.0% (subjects with diabetes).
• •8. Any contraindication to percutaneous liver biopsy.
• •9. Daily alcohol intake \>20 g (2 units)/day for women and 30 g (3 units)/day for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire.
• •10. Treatment with therapeutic doses of Vitamin E (≥800-1000 IU daily), or any of the following anti-diabetic medications: GLP-1 receptor agonists (such as Januvia \[sitagliptin\], Byetta \[incretin\], etc.), pioglitazone, or SGLT2 inhibitors ("gliflozin" drugs); unless the dose and regimen has been stable for at least 3 months.
• •11. Active rheumatoid arthritis treated with small-molecule (including methotrexate) or biologic disease-modifying anti-rheumatic agent concurrently or within 1 year.
• •12. Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids \>10 mg prednisone-equivalent concurrently or within 1 year.
• •13. More than 7 days of treatment with valproic acid, tamoxifen, amiodarone, or anti-cholinergic agents within 3 months.
• •14. Uncontrolled or clinically unstable thyroid disease.
• •15. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4), or other heart disease which is, in the Investigator's judgment, clinically unstable.
• •16. Angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months.
• •17. QTcF interval on Screening Visit ECG or an average of triplicate Baseline Visit ECGs \> 450 milliseconds (msec) for males or \> 470 msec for females.
• •18. A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome.
• •19. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes.
• •20. Active gastrointestinal disease which could interfere with the absorption of oral medication.
• •21. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that would make the patient inappropriate for entry into this study.