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ARREST Study: Phase 2b of Aramchol in NASH

ARREST Study: Phase 2b of Aramchol in NASH. 57 sites. Design. 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.

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ARREST Study: Phase 2b of Aramchol in NASH

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  1. ARREST Study: Phase 2b of Aramchol in NASH 57 sites • Design 11 countries 247 patients 13 weeksfollow-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

  2. Reduction in liver fat ARREST Study: Phase 2b of Aramchol in NASH Relative reduction > 30% > 5% absolute reduction from baseline % % Aramchol 600 vs placebo, p = 0.0279 OR = 2.77 (95% CI : 1.12 - 6.89) 50 47.0% 35 30 40 36.7% 25 30 20 24.4% 15 20 10 10 5 0 0 30% relative change Placebo(N = 41) Aramchol 400(N = 90) Aramchol 600(N = 83) Placebo • Absolute change from baseline vs placebo: • 400 mg: -3.32% ; p = 0.0450 • 600 mg: -3.09% ; p = 0.0655 Aramchol 400 mg Aramchol 600 mg Aramchol-phase 2 Ratziu V, AASLD 2018, Abs. LB5

  3. ARREST Study: Phase 2b of Aramchol in NASH ALT normalization (%) Aramchol 400 vs placebo ; p = 0.0002 Aramchol 600 vs placebo ; p < 0.0001 20 15 10 • Effect similar for AST • Statistically significant reductions inGGT and Alkaline phosphatase in both groups vs placebo 5 0 -5 -10 -15 -20 -25 W24 W40 W52 Placebo ALT statistically significant, drops pretty modest over a year Aramchol 400 mg Aramchol 600 mg Aramchol-phase 2 Ratziu V, AASLD 2018, Abs. LB5

  4. NASH resolution without worsening of fibrosis, % ARREST Study: Phase 2b of Aramchol in NASH % Averageplaceboresponse (previous Studies):FLINT,PIVENS, GENFIT, LEAN 16.7% 15% 7.5% 5% Placebo(N = 40) Aramchol 400(N = 80) Aramchol 600(N = 78) Aramchol 600 vs placebo ; p = 0.0514 OR = 4.74 (95% CI : 0.99 - 22.7) • 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

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

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