Dublin, Ireland, 5 November 2025: Afimmune, a clinical stage biopharmaceutical company developing novel rare disease therapeutics, today announced that enrolment has successfully completed in the first clinical trial evaluating Epeleuton in patients with sickle cell disease (SCD).

Clinical trial data update:

Data available to date from 28 of the 31 patients enrolled in the Epeleuton Phase 2 Sickle Cell clinical trial, representing 90% of the final dataset will be presented just before the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida on Friday December 5^th, 2025 between 2pm-4pm local time. The final dataset will be available in March 2026.

The event will include presentations from Epeleuton Study Steering Committee members;

• Biree Andemariam, MD, Professor of Medicine, Director of the New England Sickle Cell Institute at UConn Health and study lead investigator,
• Fuad El Rassi, MD, Director of the Sickle Cell Research, Georgia Comprehensive Sickle Cell Program, Associate Professor at Emory University School of Medicine and study investigator,
• Vivien Sheehan, MD, PhD, Director, Translational Sickle Cell Disease Research and Professor of Pediatrics, Emory University School of Medicine whose lab at Emory University is conducting the trial biomarker analysis.

This is an invite-only event with limited places for both in-person and online attendees. Parties can email [email protected] to register your interest in the event.

ASH Abstract Presentation:

In addition, the abstract titled, ‘A phase 2 open-label study of Epeleuton in patients with sickle cell disease’ has been accepted for presentation at the ASH conference and is now available online on the ASH website here.

Further information:

Session Date: December 8, 2025
Presentation Time: 6:00 PM – 8:00 PM
Room: OCCC – West Halls B3-B4

Publication Number: 4754

Speaker: Biree Andemariam, MD, University of Connecticut, CT

About Epeleuton

Epeleuton is 15-hydroxy eicosapentaenoic acid (15(S)-HEPE) ethyl ester, a novel synthetic fatty acid oral drug product. Epeleuton has been shown to have a unique mechanism of action for the treatment of SCD, targeting factors affecting severity, course of disease, and vaso-occlusive crisis risk.

Afimmune is developing Epeleuton for SCD due to its novel disease-modifying effects and first-in-class opportunity. Epeleuton has received orphan drug designation for the treatment of SCD from the FDA and the EMA, in addition to rare pediatric disease and fast track designations from the FDA.

About Sickle Cell Disease
SCD is a group of inherited, progressive blood disorders carried by the β allele of the hemoglobin gene with an expected 30-year reduced life expectancy. The disease is characterized by abnormal polymerization of hemoglobin during oxygenation which results in the sickling of red blood cells. The disease is rare, with an estimated prevalence of only ~100,000 people affected in the US and ~52,000 people in Europe.

About Afimmune
Afimmune, headquartered in Dublin, Ireland, is a clinical stage drug discovery and development company working on new medicines to improve the quality of life for people with rare diseases.

Contact
[email protected]