Design

• Aramchol: stearoyl-CoA desaturase receptor modulator

Endpoints

• Primary: absolute change in liver triglycerides
• Secondary: decrease in fibrosis ≥ 1, NASH resolution

Reduction in liver fat

• Absolute change from baseline vs placebo:
  • 400 mg: -3.32% ; p = 0.0450
  • 600 mg: -3.09% ; p = 0.0655

ALT statistically significant, drops pretty modest over a year

ALT normalization (%)

• Effect similar for AST
• Statistically significant reductions inGGT and Alkaline phosphatase in both groups vs placebo

NASH resolution without worsening of fibrosis, %

• In subgroups of F2/3, NAS > 4 ; Abnormal AST/AST, BMI > 30 ; HbA1C > 6,4% : NASH resolution was noted in a larger proportion of patients in the 600 mg aramchol group vs placebo

Fibrosis improvement (> 1 stage) without worsening of NASH, %

Progression to cirrhosis, %

• F2/3, NAS > 4 ; Abnormal AST/AST, BMI ≥ 30 ; HbA1C ≥ 6.4%: fibrosis improvement was noted in a larger proportion of patients in the 600 mg aramchol group vs placebo
• Abnormal ALT/AST and BMI ≥ 30: Significant difference between placebo and 600 mg aramchol