Epeleuton is also under development for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
In a mouse model of NASH, treatment with Epeleuton produced decreases of NAFLD histological findings, hepatic fat content, alanine aminotransferase (ALT) and markers of fibrosis.
In a Phase 2a study in patients with NAFLD, Epeleuton produced a dose-dependent reduction in hepatic fat assessed by controlled attenuation parameter (CAP), although changes were not significant at end-of-treatment at week 16.
Clinical trials of longer duration (52 weeks or more) will assess the full therapeutic potential of Epeleuton for the treatment of NASH.
Cardiovascular disease remains the leading cause of morbidity and mortality globally for people with NAFLD or NASH, with persistently high rates of ischemic events reported in many populations. Epeleuton is also expected to improve clinical outcomes in NASH due to its cardiometabolic effects and potential for cardiovascular risk reduction.