Swedish biopharmaceutical company Hansa Biopharma AB (STO:HNSA) announced on Monday that it has completed enrolment in its 20-HMedIdeS-19 Post Authorisation Efficacy and Safety (PAES) study, an open-label Phase 3 confirmatory study in Europe investigating the one-year patient and graft survival in highly sensitised patients who have undergone HLA-incompatible kidney transplantation following desensitisation treatment with imlifidase.

Imlifidase is Hansa's first generation, first-in-class, one-time treatment, conditionally approved in Europe as desensitisation treatment in kidney transplantation with the brand name IDEFIRIX. It is also being evaluated in late-stage trials in autoimmune diseases where immunoglobulin G (IgG) antibodies are factor of disease, and as a pre-treatment to gene therapy in patients with anti-AAV antibodies.

Hansa anticipates data readout in the second half of 2026 followed by submission to the European Medicines Agency to seek full authorisation. The PAES study is required following conditional authorisation by the European Commission for IDEFIRIX (imlifidase) in 2020.

The controlled, open-label post-authorisation efficacy and safety study aims to determine the one-year graft failure-free survival in highly sensitised kidney transplant patients with positive crossmatch against a deceased donor who received desensitisation treatment with imlifidase followed by an HLA-incompatible kidney transplantation. In addition to the 50 highly sensitised adult kidney transplant patients enrolled in the study, a total of 64 patients who underwent kidney transplantation without the need for desensitisation were included in a concurrent reference cohort and as part of the study design.