The study enrolled 50 highly sensitized patients who had a positive crossmatch against an available deceased-donor kidney and were unlikely to be transplanted under existing allocation systems, including prioritization programs. Imlifidase, an enzyme that cleaves IgG antibodies, was used to convert the crossmatch to negative before transplantation. At one year, graft survival was 92% and patient survival 98%, with a mean eGFR of 51 mL/min/1.73 m² (n=45). Delayed graft function occurred in 40% of patients and antibody-mediated rejection in 56%, although no graft losses were linked to rejection. No new safety signals were seen.

Idefirix has held a conditional marketing authorization in the EU since 2020, and PAES was designed to support a full authorization. SERB Pharmaceuticals has held the rights for transplantation in Europe and the Middle East and North Africa since July 2026. In the US, the FDA is due to decide on Hansa’s application by December 19, 2026.

“The presentation of the PAES study in the High-Impact Clinical Trials session highlights the scientific and clinical relevance of these findings and the potential of imlifidase to address a significant unmet need for highly sensitized patients awaiting kidney transplantation,” says Renée Aguiar-Lucander, CEO of Hansa Biopharma.