#Sweden #Lund #Hansa Biopharma #imlifidase #ConfIdeS Trial

Hansa Biopharma to Present Late-Breaking Findings on Imlifidase at ATC 2026

In an exciting development for kidney transplantation, Hansa Biopharma AB, traded on NASDAQ Stockholm under the symbol HNSA, has announced that results from its pivotal ConfIdeS Phase 3 trial will be presented as a late-breaking abstract at the American Transplant Congress (ATC) in Boston on June 22, 2026. The findings promise crucial insights into the treatment of highly sensitized patients, offering hope where previously limited options existed.

ConfIdeS Phase 3 Trial Details

The ConfIdeS trial focuses on kidney transplantation in highly sensitized patients—those with a pre-existing immune response that complicates the availability of compatible donor organs. These individuals represent a significant demographic on transplant waiting lists, often enduring longer wait times due to their unique immunologic profiles. This trial is especially pertinent as it investigates the use of Imlifidase, an innovative treatment designed to reduce the presence of donor-specific antibodies that pose challenges during kidney transplants.

The oral presentation will be delivered by Dr. Robert Montgomery from the New York University Langone Transplant Institute. During this session, critical data will be shared, particularly highlighting the trial's primary endpoint, eGFR (estimated Glomerular Filtration Rate), and other significant secondary endpoints alongside essential safety information. This rigorous analysis spans a 12-month duration, providing a comprehensive overview of treatment efficacy and potential risks.

Importance of the Findings

According to statistics, highly sensitized patients comprise approximately 10-15% of those on kidney transplant waiting lists across the U.S. and Europe, significantly heightening their mortality risks due to prolonged waiting times. The anticipated findings from the ConfIdeS trial could provide groundbreaking information that not only demonstrates the efficacy of Imlifidase but also reshapes the existing narrative on desensitization treatments, ultimately aiding in the improvement of outcomes for this vulnerable patient group.

Regulatory Approval and Future Directions

Imlifidase (marketed as IDEFIRIX® in the EU and other regions) is conditionally approved for use in Europe, highlighting its potential to significantly enhance the transplantation landscape for highly sensitized patients. As Hansa Biopharma continues to gather robust clinical evidence, they are also preparing to submit additional data underlining the long-term efficacy and safety of Imlifidase following post-approval studies.

The American Transplant Congress is recognized for its commitment to advancing the field of transplantation, and Hansa's participation solidifies its position at the forefront of major translational research. This presentation also aligns with global initiatives aimed at improving access to transplantation for populations facing significant barriers.

Conclusion

As we approach the ATC 2026, the excitement around Hansa Biopharma’s findings from the ConfIdeS Phase 3 trial is palpable. Their innovative approach to desensitization and the development of Imlifidase could mark a pivotal shift not only for patients waiting for kidney transplants but also for advancing therapeutic strategies in transplantation medicine. The session is set to take place at the Thomas Michael Menino Convention and Exhibition Center in Boston, and with its significance, the discussions that follow could steer future practices and protocols in the medical community.

Stay tuned for updates on this crucial topic as more information emerges from the presentation and the ongoing efforts of Hansa Biopharma to transform patient care in transplantation.