09:26 uur 26-08-2021

Afimmune’s Epeleuton vertoont grote dalingen in virale belasting en pathologische veranderingen in COVID-19-studie

Epeleuton verlaagt virale titers en SARS-CoV-2 RNA en histopathologische schade in de bovenste en onderste luchtwegen

DUBLIN–(BUSINESS WIRE)– Afimmune, een bedrijf voor de ontdekking van geneesmiddelen in de klinische fase dat zich richt op de ontwikkeling van biologisch actieve lipiden voor de behandeling van inflammatoire en cardiometabole ziekten, heeft vandaag de belangrijkste bevindingen bekendgemaakt met Epeleuton in een beproefd hamstermodel voor SARS-CoV- 2 infectie. Van Epeleuton is al aangetoond dat het ontstekingsremmende en positieve metabole effecten heeft in klinische studies bij patiënten (fase 2) die door de Vennootschap werden uitgevoerd.

Epeleuton verminderde in klinisch relevante doses de virale belasting en replicatie, zoals blijkt uit significante en dosisafhankelijke verlagingen van virale titers en SARS-CoV-2-RNA in keel, neusschelpen en longen. Bij de hogere dosis Epeleuton waren er al op dag 1 en op de piek van de virale belasting op dag 2 geen detecteerbare virale titers in de keel.

Epeleuton verminderde ook de mate en ernst van inflammatoire en histopathologische veranderingen in zowel de bovenste als de onderste luchtwegen op een dosisafhankelijke manier.

Afimmune’s Epeleuton shows large decreases in viral load and pathological changes in COVID-19 study

Epeleuton decreases viral titres and SARS-CoV-2 RNA and histopathological damage in the upper and lower respiratory tract

DUBLIN–(BUSINESS WIRE)– 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.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210826005039/en/

Dr. John Climax, Chairman and CEO of Afimmune (Photo: Business Wire)

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.”

About Epeleuton

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.

About Afimmune

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.




Halsin Partners

Mike Sinclair

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