Hansa Biopharma Reports Positive Phase 3 Results for Imlifidase in Highly Sensitized Kidney Transplant Patients

Hansa Biopharma AB (Nasdaq Stockholm: HNSA) today announced positive topline results from the US Phase 3 ConfIdeS trial of imlifidase, evaluating 12-month kidney function in highly sensitized adult kidney transplant patients (cPRA ≥99.9%) with a positive crossmatch against a deceased donor.

The trial demonstrated a statistically significant and clinically meaningful improvement in kidney function, with mean estimated Glomerular Filtration Rate (eGFR) at 12 months of 51.5 mL/min/1.73m² in the imlifidase arm versus 19.3 mL/min/1.73m² in the control arm (difference: 32.2 mL/min/1.73m², p<0.0001).

Key secondary outcomes also favored imlifidase, including dialysis independence at 12 months (p=0.0007). Imlifidase was generally well tolerated, with a safety profile consistent with prior clinical studies.

CEO Statement

Renée Aguiar-Lucander, CEO, Hansa Biopharma:

"The ConfIdeS trial data highlight the clinically meaningful benefit of imlifidase in kidney transplantation for highly sensitized patients. These results reinforce the role of imlifidase as an effective desensitization therapy and bring us closer to transforming standard of care for this patient population with very limited treatment options."

Robert Montgomery, MD, PhD, NYU Langone Health:

"The results are highly encouraging. For the first time in decades, imlifidase shows the potential to address the unmet needs of highly sensitized kidney transplant patients, many of whom have little hope of receiving a compatible organ."

About the ConfIdeS Trial

• Design: Phase 3, open-label, randomized, controlled study.
• Population: 64 highly sensitized adult kidney transplant patients (cPRA ≥99.9%) with positive crossmatch.
• Endpoints: Primary – mean eGFR at 12 months. Secondary – dialysis independence and safety.
• Sites: 25 US centers; >90% patient retention.
• Trial Duration: 5 years, including long-term follow-up under FDA accelerated approval guidance.

About Imlifidase (IDEFIRIX®)

Imlifidase is a first-in-class IgG-cleaving enzyme therapy designed to enable kidney transplantation in highly sensitized patients by rapidly cleaving IgG antibodies. It is conditionally approved in Europe, Norway, Lichtenstein, Iceland, the UK, Australia, and Switzerland.

Imlifidase is reserved for patients unlikely to be transplanted under standard kidney allocation systems, including those prioritized under programs for highly sensitized patients.

Next Steps

Hansa Biopharma plans to submit a Biologic License Application (BLA) under the FDA accelerated approval pathway by the end of 2025. Full Phase 3 results will be shared at a medical congress in 2026.

About Hansa Biopharma

Hansa Biopharma is a commercial-stage biopharmaceutical company dedicated to developing lifesaving therapies for rare immunological conditions. The company’s proprietary IgG-cleaving enzyme platform addresses unmet needs in transplantation, autoimmune diseases, and gene therapy. Hansa is listed on Nasdaq Stockholm (HNSA) and operates in Europe and the US.

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