The open-label trial enrolled 50 highly sensitised adult kidney transplant subjects. Credit: Emily Frost / Shutterstock.
Swedish biotechnology company Hansa Biopharma has finished enrolling subjects in a Phase III trial in Europe evaluating survival rates among kidney transplant subjects who have undergone desensitisation treatment with imlifidase.
The open-label 20-HMedIdeS-19 post-authorisation efficacy and safety (PAES) trial enrolled 50 highly sensitised adult kidney transplant subjects across 22 European sites.
These subjects had all received kidney transplants that were incompatible with human leukocyte antigens.
The trial also included a reference cohort of 64 subjects who underwent transplantation without desensitisation, which was added to the study to account for variations in post-transplant management across centres.
In addition, a non-comparative registry of historical data was included in the trial design.
Hansa Biopharma expects to report data from this trial in the second half of next year, with plans to submit for full authorisation to the European Medicines Agency if the results are positive.
Hansa Biopharma CEO and president Søren Tulstrup said: “The PAES study is an important part of Hansa’s continued commitment to ensuring access to potentially lifesaving Idefirix therapy for highly sensitised kidney transplant patients, as we believe that the evidence generated will support the submission for full authorisation in the European Union.
“Those considered highly sensitised and waiting for a transplant continue to face very long wait times due to their immunological status, which poses a significant barrier to finding a compatible organ.”
Marketed as Idefirix in Europe, Imlifidase has gained conditional authorisation in the region as a desensitisation treatment for kidney transplantation.
The drug is currently being assessed in late-stage studies in treating autoimmune diseases and as a pre-treatment to gene therapy in individuals with anti-adeno-associated virus antibodies.
In December 2024, Hansa Biopharma reported that imlifidase had improved motor function in individuals with Guillain-Barré Syndrome in a Phase II study.
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