Policy & Regulation
Afimmune Initiates Epeleuton Phase IIb TRIAGE Study in Patients with High Triglycerides and Type 2 Diabetes
23 September 2020 - - Dublin-based clinical stage drug discovery company Afimmune has started 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, the company said.

Epeleuton is a synthetic prodrug of an endogenous downstream metabolite of eicosapentaenoic acid.

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 %age change in triglycerides from baseline to week 16 and change in HbA1c from baseline to week 26. Data are expected in Q4 2021.

Epeleuton, previously named DS102, is 15-hydroxy eicosapentaenoic acid -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.

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, and cardiovascular disease.

The company is headquartered in Dublin, Ireland.
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