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Hansa Biopharma Concludes Enrollment in Groundbreaking Phase 3 Study

Hansa Biopharma AB, known simply as Hansa, has recently reached a significant milestone in the medical field by completing enrollment for its 20-HMedIdeS-19 Post Authorization Efficacy and Safety study. This study is particularly focused on highly sensitized kidney transplant patients who have undergone HLA-incompatible kidney transplants after treatment with imlifidase, the company’s first-in-class therapeutic. Imlifidase has been conditionally approved in Europe as a desensitization treatment under the commercial name IDEFIRIX®.

The study, which is classified as an open-label Phase 3 confirmatory trial, aims to assess the one-year survival rates of both patients and grafts in this challenging patient population. The need for such innovative treatments is underscored by the significant barriers that highly sensitized patients face—typically characterized by long waiting periods and complications in finding compatible donor organs due to their complex immunological profiles.

Background on Highly Sensitized Patients

Patients who are highly sensitized possess pre-formed antibodies that can lead to rejection of transplanted organs. These antibodies, known as donor-specific antibodies (DSAs), create a formidable obstacle in the transplantation process. Globally, it is estimated that about 10-15% of individuals awaiting transplants fall into this category, translating to increased waiting times and, consequently, elevated mortality risks.

Recognizing the urgent need for effective solutions, Hansa Biopharma has committed itself to providing therapies that can potentially save lives. The efficacy of imlifidase lies in its ability to cleave IgG antibodies, thereby paving the way for patients previously deemed ineligible for transplant to finally access suitable kidney donations.

Study and Anticipated Outcomes

The PAES study encompasses 50 highly sensitized adult kidney transplant patients, complemented by a reference cohort that consists of 64 other kidney transplant patients who did not require desensitization treatment. By including this diverse participant pool, researchers hope to obtain a comprehensive view of the different outcomes associated with various transplant management strategies in Europe.

Hansa Biopharma's goal is to present robust data by the latter half of 2026, followed by a submission to the European Medicines Agency to seek full authorization for IDEFIRIX. Søren Tulstrup, the company’s President and CEO, highlights the importance of this study, stressing that it firmly supports the potential for IDEFIRIX to become a viable treatment option for highly sensitized patients waiting for transplants.

Dr. Thomas Lorant, a key transplant surgeon involved in the study, expresses optimism regarding imlifidase’s capabilities in transforming transplantation care. He notes the treatment’s function of creating an “IgG-free window,” which serves to neutralize donor-specific antibodies. This advancement could significantly affect the lives of patients who have faced an indefinite wait for a compatible organ on transplantation lists.

Conclusion

Hansa Biopharma aims to bring much-needed attention and hope to a patient population that has historically struggled with access to life-saving treatments. By conducting the 20-HMedIdeS-19 study, they seek not only to validate the effectiveness of imlifidase in clinical settings but also to contribute valuable insights that could reform how highly sensitized transplant patients are managed in the future. With the completion of participant enrollment, the focus now shifts to rigorous data collection and analysis—steps that could usher in a new era of transplant possibilities for those most in need.