A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment

Inclusion criteria

• Able to provide written informed consent (either from subject or subject's legally acceptable representative).
• Onset of jaundice within prior 8 weeks.
• Average daily consumption of >40 (females) or >60 (males) grams of alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice.
• The determination of AH may be based on typical serum chemistry (as determined by local laboratory) or liver biopsy at any time during the current episode of AH:

• Serum total bilirubin > 3.0 mg/dL
• 50 < AST < 400 IU/L
• ALT < 400 IU/L
• AST/ALT > 1.5
• Maddrey discriminant function (MDF) ≥ 32 assuming a control prothrombin time of 12 seconds.
• Model for End-stage Liver Disease (MELD) score: 21-30.
• Liver biopsy is not required, but may be used to confirm the diagnosis of AH at the Investigator's discretion. Biopsy, if used as a diagnostic criterion, must have occurred during the current episode.
• Male or female subjects 18 years of age or older.
• Subjects must agree to use effective methods to prevent pregnancy while participating in the study.
• Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists.

Exclusion criteria

• Subjects taking systemic corticosteroids for a duration exceeding 8 days in the 30 days prior to screening.
• Subjects experiencing or considered at high risk for alcohol withdrawal seizures or delirium tremens.
• Active infection (such as spontaneous bacterial peritonitis [SBP], urinary tract infection [UTI], bacteremia, acute viral hepatitis, uncontrolled HIV, and active SARS CoV2 infection).
• Serum creatinine >2.5 mg/dL.
• Subjects undergoing continuous veno-venous hemodialysis (CVVH).
• Uncontrolled gastrointestinal bleeding.
• A history of pre-admission refractory ascites defined as more than 4 paracenteses in the previous 8 weeks despite diuretic therapy.
• Liver biopsy (if carried out) with findings not compatible with AH.
• Stage ≥3 hepatic encephalopathy by West Haven criteria.
• Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure.
• Other concomitant cause(s) of liver disease.
• Any active malignancy or any malignancy diagnosed within the last five years other than curable skin cancer (basal cell or squamous cell carcinomas).
• Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications.
• Existing or intended pregnancy or breast feeding.
• Participation in another interventional clinical trial within 30 days of Screening.
• History of organ transplantation, other than a corneal transplant.
• Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.