Aramchol (arachidyl amido cholanoic acid; Galmed) is a conjugate of cholic acid and arachidic acid, and belongs to the synthetic fatty acid bile acid conjugates (FABACs) family. Aramchol inhibits the liver enzyme stearoyl-CoA desaturase 1 inhibitor (SCD1), and as a result fatty acid synthesis is reduced while fatty acid oxidation is increased. Additionally, Aramchol has hypocholesterolemic effects due to the upregulation of ATP-binding cassette transporter 1 (ABCA1). Ultimately, Aramchol causes incomplete SCD inhibition while also being anti-atherogenic.
Data from the Phase IIb ARREST study, which investigated the efficacy and safety of two doses of Aramchol in biopsy-confirmed non-alcoholic steatohepatitis (NASH) patients with obesity and diabetes, were mixed with a high degree of variability. Despite the lack of statistical significance, likely due to a small sample size, the positive trend in NASH resolution without worsening of fibrosis observed with the 600mg dose of Aramchol was deemed sufficient to initiate the Phase III ARMOR study using the 600mg dose. Significantly more patients in the 600mg group achieved a >5% reduction in absolute change from baseline in liver fat compared to placebo. However, there was a greater reduction in liver fat from baseline (the primary endpoint) in the 400mg group compared to the 600mg group. The inconsistent results indicate that there is substantial variability between the individual patient responses, which raises the question of the replicability of these results in the Phase III trial. If approved, Aramchol will likely experience greatest uptake in obese and type 2 diabetic patients, reflecting the characteristics of patients in the Phase IIb ARREST study. Though these co-morbidities often occur in NASH patients (diabetes = 44%; obesity = 48% in the US), it could restrict Aramchol to a subset of the NASH population. The exact details for the Phase III ARMOR trial have not been revealed, therefore it is unclear whether Galmed will attempt to expand Aramchol’s patient population beyond the groups enrolled in the ARREST study.
LIST OF FIGURES
10 Figure 1: Datamonitor Healthcare’s drug assessment summary of Aramchol for NASH
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of Aramchol for NASH
13 Figure 3: Aramchol sales for NASH across the US and five major EU markets, by country, 2018–27
LIST OF TABLES
6 Table 1: Aramchol drug profile
8 Table 2: Late-phase trials of Aramchol for NASH
9 Table 3: Aramchol for NASH – SWOT analysis
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