DUBLIN--(BUSINESS WIRE)--Afimmune, a clinical stage drug discovery company focused on the development of biologically active polyunsaturated lipids for the treatment of cardiometabolic diseases, announced today the start of TRIAGE (TRIglyceride And Glucose control with Epeleuton in Metabolic Syndrome Patients), a Phase IIb study of epeleuton in patients with high triglycerides and type 2 diabetes. Epeleuton is a synthetic prodrug of an endogenous downstream metabolite of eicosapentaenoic acid (EPA).
“In a Phase IIa study in patients with non-alcoholic fatty liver disease (NAFLD), epeleuton not only significantly lowered triglycerides and cholesterol but also statistically and clinically significantly reduced HbA1c and fasting glucose,” said Dr. John Climax, CEO of Afimmune. “Beyond this epeleuton was found to be very safe with no treatment related serious adverse events. These data lead us to believe that epeleuton could be effective in metabolic syndrome patients as a first-in-class, safe and effective treatment for cardiovascular risk reduction and type 2 diabetes.”
TRIAGE (ClinicalTrials.gov Identifier: NCT04365400) is a randomised, double-blind, placebo-controlled, dose finding Phase IIb study being conducted in Germany, Israel, Latvia, Switzerland 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. Data are expected in Q4 2021.
“In addition to lowering triglycerides, epeleuton meaningfully decreased HbA1C, a novel finding for an omega 3 fatty acid. These data suggest that epeleuton may have significant potential for cardiovascular risk reduction by simultaneously targeting multiple cardiometabolic risk factors. TRIAGE is an important next step to clarify these findings,” commented Prof Deepak L. Bhatt, M.D. M.P.H, executive director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital Heart and Vascular Center, professor of medicine at Harvard Medical School, and chair of the TRIAGE trial.
Epeleuton, previously named DS102, is 15-hydroxy eicosapentaenoic acid (15(S)-HEPE) ethyl ester, a second-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.
Afimmune is a clinical stage drug discovery and development company developing biologically active polyunsaturated lipids for the treatment of metabolic disorders, such as dyslipidemia, type 2 diabetes, non-alcoholic steatohepatitis (NASH), and cardiovascular disease. The company is headquartered in Dublin, Ireland. For more information, visit www.afimmune.com.