Dublin, Ireland, 18th September 2024 – Afimmune, a clinical stage drug discovery and development company, today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 12,076,304 “Compositions Comprising 15-HEPE and Methods of Treating or Preventing Hematologic Disorders, and/or Related Diseases”.

The broad claims protect the use of Epeleuton for the treatment of Sickle Cell Disease (SCD) and other red blood disorders. These claims will be valid until 2040 at least.

“This US patent grant is another important achievement for Afimmune, adding a method of use patent for SCD treatment to a strong Epeleuton patent portfolio. Together with its FDA Fast Track and Rare Pediatric Disease Designations, the Epeleuton programme is well-positioned to progress to Phase 3 development following results, expected in 2025, of the ongoing Phase 2 study in SCD patients” said Mr. Tien Nghiem, Senior Director of Product Development and Intellectual Property.

About Epeleuton

Epeleuton is a 15-hydroxy eicosapentaenoic acid (15(S)-HEPE) ethyl ester, a novel synthetic fatty acid drug product. Epeleuton has been shown to have a unique dual 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 preclinical efficacy, first-in-class opportunity, and a significantly reduced regulatory pathway.  Epeleuton has received orphan drug designation for the treatment of SCD from the FDA. A phase 2 study of Epeleuton is currently being enrolled in sites across North America. For more information, please visit https://clinicaltrials.gov/study/NCT05861453.

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 the EU.

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 and inflammatory diseases. For more information on Afimmune, visit www.afimmune.com.

Contact
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