#Sweden #Lund #kidney transplant #Hansa Biopharma #IDEFIRIX

Hansa Biopharma Completes Enrollment in Key Phase 3 Study

Lund, Sweden, has become a pivotal point in kidney transplantation studies as Hansa Biopharma AB recently announced the completion of enrollment in its Phase 3 study, titled 20-HMedIdeS-19. This significant research aims to assess the efficacy and safety of its innovative treatment, Imlifidase, a first-in-class enzyme, designed for highly sensitized kidney transplant patients.

The study follows the conditional approval of Imlifidase under the brand name IDEFIRIX®, which serves as a desensitization treatment for patients with highly sensitized immune profiles. These individuals often face long wait times for compatible organs due to the presence of donor-specific antibodies (DSAs) that complicate potential transplants. Hansa's trial is particularly timely, focusing on one-year patient and graft survival rates post-transplantation.

Importance of the Study

Hansa's President and CEO, Søren Tulstrup, emphasized the study’s relevance by stating, "The PAES study underscores our commitment to providing access to essential therapies like IDEFIRIX for patients who are highly sensitized and face significant barriers in the transplantation process." The clinical trial seeks to address the urgent needs of a demographic that constitutes about 10-15% of patients waiting for kidney transplants in the U.S. and Europe.

Key Features of the Research

The 20-HMedIdeS-19 study is an open-label, controlled study enrolling 50 highly sensitized adult patients who underwent desensitization with Imlifidase prior to receiving an HLA-incompatible kidney transplant. Additionally, 64 patients who had successful transplantations without needing desensitization were included as a reference group to account for variability in post-transplant management practices.

The primary objective is to assess the one-year graft failure-free survival in both groups. Data is expected to be available in the latter half of 2026, which Hansa plans to use in its submissions for full authorization to the European Medicines Agency (EMA).

The Transformation of Kidney Care

Transplant surgeon Thomas Lorant from Uppsala University, the study's coordinating investigator, highlighted the revolutionary impact of Imlifidase on the treatment landscape for highly sensitized patients: "By creating an IgG-free environment, Imlifidase facilitates a viable option for those previously stuck on transplant waiting lists due to their immunological profiles. This breakthrough therapy indeed holds promise for those who encounter the highest challenges in accessing transplant care."

Future Directions

Hansa Biopharma is not only committed to serving highly sensitized kidney patients but is also researching Imlifidase’s potential in treating autoimmune diseases, where IgG antibodies contribute to adverse health effects. As the healthcare landscape for transplants evolves, the findings from this study could lead to improved protocols that enhance outcomes for those with complex immunological challenges.

In summary, the completion of enrollment in this crucial phase 3 clinical trial by Hansa Biopharma is a noteworthy advancement for the field of kidney transplantation. By focusing on a population with significant medical needs, Hansa is paving the way for future innovations that could potentially transform the lives of many patients waiting for life-saving organ transplants.