1. ARREST Study: Phase 2b of Aramchol in NASH
Design
57 sites
11 countries
247 patients
13 weeks follow-up
Diabetic or pre-diabetic
NAS ≥ 4
MRS > 5.5%
52 weeks
Randomization
1:2:2
Placebo N = 48
Aramchol 400 mg
Aramchol 600 mg
Baseline
End of treatment
MR spectroscopy
MR spectroscopy
Liver biopsy
Liver biopsy
Aramchol: stearoyl-CoA desaturase receptor modulator
Endpoints
Primary: absolute change in liver triglycerides
Secondary: decrease in fibrosis ≥ 1, NASH resolution
Aramchol-phase 2
Ratziu V, AASLD 2018, Abs. LB5 1

2. Relative reduction > 30% > 5% absolute reduction from baseline
ARREST Study: Phase 2b of Aramchol in NASH
Reduction in liver fat
Relative reduction > 30%
> 5% absolute reduction from baseline 10 20 30 35 5 15 25
30% relative change %
Aramchol 600 vs placebo, p =
OR = 2.77 (95% CI : ) 50 40 30 20 10
Placebo (N = 41)
Aramchol 400 (N = 90)
Aramchol 600 (N = 83)
36.7%
47.0%
24.4% %
Placebo
Absolute change from baseline vs placebo:
400 mg: -3.32% ; p =
600 mg: -3.09% ; p =
Aramchol 400 mg
Aramchol 600 mg
Aramchol-phase 2
Ratziu V, AASLD 2018, Abs. LB5 2

3. ARREST Study: Phase 2b of Aramchol in NASH
ALT normalization (%) 5 10 15 20 -5
-10
-15
-20
-25
W24
W40
W52
Aramchol 400 vs placebo ; p =
Aramchol 600 vs placebo ; p <
ALT statistically significant, drops pretty modest over a year
Placebo
Aramchol 400 mg
Aramchol 600 mg
13.3
21.9 29
Effect similar for AST
Statistically significant reductions in GGT and Alkaline phosphatase in both groups vs placebo
Aramchol 600 mg
Placebo
Aramchol 400 mg
Aramchol-phase 2
Ratziu V, AASLD 2018, Abs. LB5 3

4. NASH resolution without worsening of fibrosis, %
ARREST Study: Phase 2b of Aramchol in NASH
NASH resolution without worsening of fibrosis, % %
Placebo (N = 40)
Aramchol 400 (N = 80)
Aramchol 600 (N = 78) 5%
7.5%
16.7%
Aramchol 600 vs placebo ; p =
OR = 4.74 (95% CI : )
15%
Average placebo response
(previous
Studies): FLINT, PIVENS,
GENFIT,
LEAN
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
Aramchol-phase 2
Ratziu V, AASLD 2018, Abs. LB5 4

5. ARREST Study: Phase 2b of Aramchol in NASH
Fibrosis improvement (> 1 stage) without worsening of NASH, %
Progression to cirrhosis, % % %
Placebo (N = 40)
Aramchol 400 (N = 80)
Aramchol 600 (N = 78)
17.5
21.3
29.5
p = 0.21
Placebo (N = 40)
Aramchol 400 (N = 80)
Aramchol 600 (N = 78)
N = 6
N = 3
N = 1
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
Aramchol-phase 2
Ratziu V, AASLD 2018, Abs. LB5 5