#Sweden #Lund #kidney transplant #Hansa Biopharma #imlifidase

Hansa Biopharma Unveils Five-Year Study Results at ESOT Congress 2025

In an impactful presentation at the 2025 International Transplant Congress held by the European Society for Organ Transplantation (ESOT) in London, Hansa Biopharma AB reported exciting developments regarding its antibody-cleaving enzyme therapy, Imlifidase. This session shed light on five years of follow-up data from the pivotal study 17-HMedIdeS-14, focusing on kidney transplantation outcomes for highly sensitized patients.

The extended pooled analysis included critical data on patient survival and graft success rates. According to the analysis, which involved patients treated with Imlifidase, the five-year survival rate stood at an impressive 90%, with graft survival (censored for death) recorded at 82%. These figures indicate sustained positive outcomes, especially considering the challenges faced by highly sensitized individuals who often have a limited pool of compatible donor organs.

Understanding Imlifidase
Imlifidase, marketed under the name IDEFIRIX, functions by cleaving immunoglobulin G (IgG) antibodies, enabling greater chances of successful transplants in patients with donor-specific antibodies who figure prominently among those waiting for kidney transplants. It has been a game-changer for highly sensitized patients who have antibodies that generally hinder their eligibility for transplants. Currently, these patients constitute about 10-15% of those on waiting lists across the U.S. and Europe, often enduring longer wait times correlated with increased mortality risks.

Key Outcomes of the Study
Presented by Dr. Massimo Mangiola from NYU Langone Transplant Institute, the findings reiterate the durability of outcomes achieved post-transplant with Imlifidase treatment. The mean estimated glomerular filtration rate (eGFR) at five years for these treated patients was calculated at 50 mL/min/m², a crucial measure of kidney function. To put this into context, the average eGFR for kidney transplant recipients typically ranges from 40-60 mL/min per 1.73 m² three years after their transplant, with many experiencing a decline thereafter. The consistent performance post-Imlifidase treatment signifies a noteworthy breakthrough in managing kidney transplants effectively.

Dr. Hitto Kaufmann, Chief RD Officer at Hansa Biopharma, expressed optimism over these results, stating, "The ongoing interest and enthusiasm from the clinical community surrounding the extended analysis results further validate our approach. This study represents a first of its kind, demonstrating that HLA-incompatible transplants following desensitization with Imlifidase provide a substantial long-term benefit—a viable option that could transform the lives of patients dependent on dialysis.”

Comprehensive Research Program
The analysis ties into a broader clinical program exploring Imlifidase, which includes multiple global trials and ongoing studies aimed at refining usage for patients in need of life-saving transplants. The program encompasses the initial phase trials and a post-authorization efficacy and safety study in Europe.

The 17-HMedIdeS-14 study is particularly vital as it involves participants consenting to the long-term follow-up of their treatment journey, contributing to a growing body of evidence around the efficacy and safety of Imlifidase as a pre-transplant strategy.

Broader Implications
Kidney failure affects nearly 2.5 million people globally, and the standard treatment—dialysis—cannot compare to the survival and quality of life improvements associated with kidney transplants. With approximately 170,000 patients currently waiting for transplants in the U.S. and Europe, the impact of innovations like Imlifidase cannot be overstated.

Hansa Biopharma continues to lead in developing cutting-edge therapies that address significant unmet medical needs in transplantation, signaling a promising horizon for both healthcare providers and patients alike. For more details about Hansa Biopharma, visit www.hansabiopharma.com.

The future of transplant medicine looks brighter with emerging therapies like Imlifidase paving the way towards more inclusive and successful transplantation opportunities for all patients, regardless of their sensitization status.