Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation
At 12 months, mean eGFR was 51.5 mL/min/1.73m2 in the imlifidase arm versus 19.3 mL/min/1.73m2 in the control arm with a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m2 ( p<0.0001)
Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience
Submission of a Biologic License Application (BLA) under accelerated approval pathway planned for end of 2025
Lund, Sweden, 24 September 2025. Hansa Biopharma AB, (“Hansa” or “the Company”), (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 (cPRA ≥99.9%) adult kidney transplant patients with positive crossmatch against a deceased donor, versus the control arm. The trial was well conducted, with patient retention in excess of 90%, and met the primary endpoint of kidney function at 12 months as measured by mean estimated Glomerular Filtration Rate (eGFR) with a p-value of <0.0001. The Company plans to submit a BLA under the accelerated approval pathway to the US Food and Drug Administration (FDA) by the end of 2025.
