·       Epeleuton reduced the annualised rate of vaso-occlusive crises (VOCs) leading to a healthcare visit by 57.4% versus the prior-year baseline (p=0.0001).

·       62.1% of evaluable participants achieved ≥50% reduction in annualised VOC rate.

·       Afimmune plans to advance epeleuton into a randomised Phase 3 study in adults and adolescents with sickle cell disease.

DUBLIN, Ireland, June 2nd, 2026 — Afimmune Ltd., a clinical-stage biopharmaceutical company developing treatments for rare diseases, today announced positive results from a Phase 2 trial of oral epeleuton in adults with sickle cell disease (SCD). The results showed a statistically significant reduction in VOCs, alongside improvements in red blood cell (RBC) function and cellular adhesion biomarkers.

Epeleuton is an oral, novel synthetic fatty acid therapy being developed to treat SCD, a serious, life-threatening inherited blood disorder in which recurrent VOCs cause severe pain, hospitalisation, and progressive disease complications.

The 16-week Phase 2 trial evaluated oral epeleuton 2g twice daily in adults with SCD and recurrent VOCs (NCT05861453). The study compared VOC rates during treatment with each participant’s documented VOC rate in the 12 months prior to study entry.

In the trial, the mean annualised rate of VOCs leading to a healthcare visit decreased from 3.97 events in the 12 months before study entry to 1.95 events during treatment, representing a 57.4% reduction from baseline (p=0.0001). This endpoint is planned as the primary efficacy endpoint in Afimmune’s planned Phase 3 study.

Most participants experienced a reduction in VOC burden and 62.1% of evaluable participants achieved a ≥50% reduction in annualised healthcare-visit VOC rate.

Treatment with epeleuton also significantly reduced abnormal cell adhesion implicated in vaso-occlusion and improved key measures of red blood cell function, including reduced sickling and improved hydration.

In the trial, epeleuton had a safety profile consistent with previous epeleuton trials and was well tolerated overall.

“Sickle cell disease places a substantial burden on patients, particularly through recurrent painful vaso-occlusive crises that can require urgent medical care and hospitalization. The reduction in healthcare-visit VOCs observed with epeleuton is very encouraging and was accompanied by improvements in biomarkers linked to the underlying biology of vaso-occlusion. These findings strongly support further evaluation in a Phase 3 study.” said Dr. Biree Andemariam, MD, Professor of Medicine and Director of the New England Sickle Cell Institute at UConn Health, and lead investigator of the study.

“These data represent an important milestone for Afimmune and reinforce the potential of epeleuton as an effective and safe oral therapy for sickle cell disease. We look forward to sharing the detailed data with our industry colleagues at future scientific conferences and advancing into Phase 3 development.” said Dr. John Climax, PhD, Chairman and CEO of Afimmune.

About Sickle Cell Disease

Sickle cell disease (SCD) is a group of rare, inherited, life-threatening blood disorders driven by the polymerisation of abnormal sickle haemoglobin (HbS) in red blood cells. Approximately 100,000 people living with SCD are in the United States, as well as approximately 110,000 in Europe.

Recurrent VOCs are a major hallmark of SCD, where sickled and abnormally adherent blood cells obstruct blood flow. VOCs can cause severe pain, emergency healthcare visits and hospitalisation, and contribute to progressive organ damage. SCD is also associated with serious acute and chronic complications, including acute chest syndrome, stroke, cognitive impairment and multi-organ damage.

Despite advances in treatment, many people with SCD continue to experience substantial pain, recurrent VOCs and reduced life expectancy.

About Epeleuton

Epeleuton is 15-hydroxy eicosapentaenoic acid (15(S)-HEPE) ethyl ester, a novel synthetic fatty acid orally administered small molecule.

Epeleuton is being developed for the treatment of SCD, with the aim of reducing VOC burden by targeting key contributors to vaso-occlusion, including impaired red blood cell function, sickling and abnormal cellular adhesion.

About Afimmune

Afimmune Ltd. is a clinical-stage biopharmaceutical company dedicated to developing first-in-class treatments for rare diseases.

Its lead programme, epeleuton, is in late-stage development for sickle cell disease and holds Orphan Drug Designation, Fast Track Designation and Rare Pediatric Disease Designation from the FDA.

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