Elafibranor (Genfit) is an oral peroxisome proliferator-activated receptor (PPAR) alpha-delta dual agonist. The medication activates PPAR-alpha and PPAR-delta, which control gene expression. Stimulating these receptors increases insulin sensitivity and fatty acid oxidation, which results in a reduction of fat buildup in the liver and leads to a decrease in fibrosis and inflammation. Elafibranor has also been shown to increase high-density lipoprotein levels, which may provide additional cardiovascular benefits.
Elafibranor has experienced mixed results in its Phase IIb GOLDEN trial due to the inclusion of non-alcoholic steatohepatitis (NASH) patients with Non-Alcoholic Fatty Liver Disease Activity Score (NAS) of 3 or above, rather than 4, which is usually required for NASH trials. This diluted the effect of the drug and likely contributed to the failure of elafibranor to meet the predefined primary endpoint of NASH resolution with no worsening fibrosis. However, a separate analysis that only included patients with a NAS score of 4 or above showed that significantly more patients in the 120mg elafibranor-treated group (19%) experienced the modified definition of NASH resolution compared to the placebo group (9%).
LIST OF FIGURES
10 Figure 1: Datamonitor Healthcare’s drug assessment summary of elafibranor for NASH
11 Figure 2: Datamonitor Healthcare’s drug assessment summary of elafibranor for NASH
13 Figure 3: Elafibranor sales for NASH across the US and five major EU markets, by country, 2018–27
LIST OF TABLES
6 Table 1: Elafibranor drug profile
8 Table 2: Late-phase trials of elafibranor for NASH
9 Table 3: Elafibranor for NASH – SWOT analysis
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