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ARREST Study: Phase 2b of Aramchol in NASH

The ARREST Study Phase 2b of Aramchol in NASH involved 57 sites across 11 countries with 247 patients. The study focused on liver triglyceride reduction and fibrosis improvement using Aramchol, a stearoyl-CoA desaturase receptor modulator. Results showed significant efficacy in treating NASH, with notable outcomes on liver fat reduction and normalization of ALT levels.

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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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