DUBLIN--(BUSINESS WIRE)--Afimmune, a clinical stage drug discovery company focused on the development of biologically active lipids for the treatment of cardiometabolic diseases, today announced key findings with epeleuton from preclinical atherosclerosis studies. Epeleuton is a next-generation synthetic n-3 fatty acid, which was shown to have clinically meaningful triglyceride lowering, anti-hyperglycemic and anti-inflammatory effects in a phase 2a clinical trial conducted by Afimmune.
Atherosclerosis is the leading cause of cardiovascular disease globally. Any new therapeutic that can decrease or prevent atherosclerosis is expected to have a significant impact on cardiovascular outcomes, including mortality.
In the well-established LDL receptor knockout mouse model of atherosclerosis, 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 statistically significantly decreased triglycerides, cholesterol and inflammatory markers, including serum interleukin-1 beta (IL-1β).
Commenting on the results, Dr. John Climax, CEO of Afimmune said: “Our phase 2a clinical trial suggested that epeleuton may have potential for cardiovascular risk reduction by simultaneously targeting multiple cardiometabolic risk factors, including high triglycerides and type 2 diabetes. The strong effects of epeleuton on atherosclerosis, shown for the first time in these preclinical studies, further emphasises the exciting therapeutic potential of this novel omega 3 drug. The ongoing phase 2b TRIAGE study is an important next step in the development of epeleuton as a first and best-in-class treatment for cardiovascular risk reduction and type 2 diabetes.”
Epeleuton, previously named DS102, is 15-hydroxy eicosapentaenoic acid (15(S)-HEPE) ethyl ester, a next-generation synthetic n-3 fatty acid and derivative of an endogenous downstream metabolite of EPA. Epeleuton is a new chemical entity with additional therapeutic effects compared with other n-3 fatty acids.
The epeleuton phase 2a data is published in the peer-reviewed Journal of the American Heart Association (JAHA). The paper can be found here.
About the TRIAGE trial
TRIAGE (ClinicalTrials.gov Identifier: NCT04365400) is a randomised, double-blind, placebo-controlled, dose finding phase 2b study being conducted in Europe and the United States to assess the efficacy and safety of orally administered epeleuton in 240 patients with hypertriglyceridemia and type 2 diabetes. Patients will receive either epeleuton (2 or 4 g/day) or placebo for 26 weeks. The primary outcomes will be percentage change in triglycerides from baseline to week 16 and change in HbA1c from baseline to week 26. Results are expected around Q3 2022.
Afimmune is a clinical stage drug discovery and development company developing biologically active lipids for the treatment of metabolic disorders, such as dyslipidemia, type 2 diabetes, cardiovascular disease and non-alcoholic steatohepatitis (NASH). The company is headquartered in Dublin, Ireland. For more information, visit www.afimmune.com.