Hansa Biopharma AB has announced positive topline results from the US Phase 3 ConfIdeS trial evaluating imlifidase in highly sensitized adult kidney transplant patients with a positive crossmatch against a deceased donor. The trial met its primary endpoint of kidney function at 12 months, with mean estimated Glomerular Filtration Rate (eGFR) of 51.5 mL/min/1.73m² in the imlifidase arm versus 19.3 mL/min/1.73m² in the control arm, a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m² (p<0.0001).

Renée Aguiar-Lucander, CEO of Hansa Biopharma, said: “We are excited to share the data from the US ConfIdeS trial, which clearly shows the clinically meaningful benefit of imlifidase in kidney transplantation of highly sensitized patients, and the role it can play in shaping future standard of care. These results corroborate the existing clinical and real-world evidence of the use of imlifidase as an effective desensitization therapy in kidney transplantation. We look forward to sharing this body of data with the FDA in our mission to bring this medicine to these patients who today have very limited options.”

Patients receiving imlifidase showed superior kidney function at 12 months compared to controls, who were offered a range of treatments including remaining on dialysis, transplantation using off-label desensitization approaches, or transplantation with a compatible organ. A key secondary endpoint, dialysis independence at 12 months, was also statistically significant in favor of imlifidase (p=0.0007). The therapy was generally well tolerated, with a safety profile consistent with prior clinical experience.

Robert Montgomery, MD, PhD, New York University Langone Health, added: “There have been few major breakthroughs in desensitization strategies in kidney transplantation for the last 30 years. The unmet need remains high for kidney transplant patients who are considered highly sensitized. The results from the US ConfIdeS trial are highly encouraging and demonstrate the significant potential for imlifidase to transform standard of care for these patients.”

Hansa Biopharma plans to submit a Biologic License Application under the FDA’s accelerated approval pathway by the end of 2025. Full trial results will be presented at a medical congress in 2026.