Afimmune's Epeleuton shows large decreases in viral load and pathological changes in COVID-19 study
Afimmune, a clinical stage drug discovery company focused on the development of biologically active lipids for the treatment of inflammatory and cardiometabolic diseases, today announced key findings with Epeleuton in a well-established hamster model for SARS-CoV-2 infection. Epeleuton has already been shown to have anti-inflammatory and positive metabolic effects in clinical trials in patients (phase 2) conducted by the Company.
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Dr. John Climax, Chairman and CEO of Afimmune (Photo: Business Wire)
Epeleuton at clinically relevant doses decreased viral load and replication as evidenced by significant and dose-dependent decreases of viral titres and SARS-CoV-2 RNA in throats, nasal turbinates and lungs. At the higher Epeleuton dose, as early as day 1 and on the peak of viral load on day 2, there were no detectable viral titres in the throat.
Epeleuton also decreased the extent and severity of inflammatory and histopathological changes in both the upper and lower respiratory tracts in a dose-dependent manner.
“As concerns about development of resistance to monoclonal antibodies grow, access to a variety of treatment approaches becomes more important. These data suggest complete respiratory tract coverage and indicates the therapeutic potential of Epeleuton as a safe and effective oral outpatient treatment for COVID-19,” said Dr. John Climax, CEO of Afimmune.
Commenting further on the results, Dr. John Climax said: “These preclinical data suggests that Epeleuton has potential to reduce COVID-19 disease burden and risk of hospitalisation due to the dual action of the direct antiviral effects against SARS-CoV-2 and the already proven anti-inflammatory outcomes. The potency of Epeleuton on viral load, replication, and histopathological improvement on both the upper and lower respiratory tract underline the therapeutic potential of Epeleuton in COVID-19 and possibly in long COVID. These unique findings will soon be published. Discussions are ongoing with regulatory agencies and potential partners so that the Company can quickly commence further clinical trials with Epeleuton, a much-needed treatment option for COVID-19.”
Epeleuton, previously named DS102, is 15-hydroxy eicosapentaenoic acid (15(S)-HEPE) ethyl ester, a derivative of an endogenous downstream metabolite of EPA. Epeleuton is a new chemical entity.
Epeleuton's cardiometabolic and anti-inflammatory data (phase 2) has been published in the peer-reviewed Journal of the American Heart Association (JAHA). The paper can be found here.
Epeleuton is also 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 patients with hypertriglyceridemia and type 2 diabetes. Patients will receive either Epeleuton 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 in addition to COVID-19 and non-alcoholic steatohepatitis (NASH). The company is headquartered in Dublin, Ireland. For more information, visit www.afimmune.com.
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