Epeleuton is under development for the treatment of hypertriglyceridemia, type 2 diabetes (first-in-class) and cardiovascular risk reduction.
Clinical and preclinical data indicate the potential of Epeleuton for cardiovascular risk reduction.
In a mouse model of atherosclerosis sponsored by Afimmune, treatment with Epeleuton produced statistically significant and dose-dependent decreases of both total aortic plaque area and aortic root plaque. In addition to these large reductions in atherosclerosis progression, Epeleuton significantly decreased triglycerides, cholesterol and inflammatory markers, including serum interleukin-1 beta (IL-1β).
In a Phase 2a clinical trial treatment with Epeleuton resulted in statistically significant decreases of triglycerides, HbA1C, plasma glucose, and inflammatory markers. These data suggested that Epeleuton may have potential for cardiovascular risk reduction by simultaneously targeting hypertriglyceridemia, hyperglycemia, and systemic inflammation.
Epeleuton’s Phase 2a cardiometabolic and inflammatory data is published in the peer-reviewed Journal of the American Heart Association (JAHA). The paper can be found here.
Epeleuton is currently being investigated in TRIAGE (ClinicalTrials.gov Identifier: NCT04365400), a randomised, double-blind, placebo-controlled, dose finding Phase 2b study which is being conducted in Europe and the United States to assess the efficacy and safety of orally administered Epeleuton in patients with hypertriglyceridemia and type 2 diabetes.
Patients will receive either Epeleuton (2 or 4 g/day) or placebo for 26 weeks. The primary endpoints are e percentage change in triglycerides from baseline to week 16 and change in HbA1c from baseline to week 26. Results are expected around Q.1 2023.