Swedish biopharmaceutical company Hansa Biopharma (STO:HNSA) announced on Thursday that it has completed the enrolment of patients in the GOOD-IDES-02 trial of imlifidase.

The global pivotal Phase 3 trial with 50 participants will assess imlifidase in the treatment of anti-glomerular basement membrane (anti-GBM) disease, a rare, severe autoimmune condition affecting around 1.6 people per million annually.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted orphan drug designation to imlifidase for the treatment of anti-GBM disease.

Soren Tulstrup, Hansa Biopharma president and CEO, said: "The completion of patient enrolment in this pivotal Phase 3 trial is an important milestone in our efforts to investigate the potential role for imlifidase to address the high unmet need in anti-GBM. The majority of patients with anti-GBM today lose kidney function and two-thirds experience kidney failure requiring long-term dialysis. We look forward to sharing further updates on the outcome of the study and potential path forward in 2025."

Imlifidase has conditional marketing approval in Europe and is marketed under the trade name IDEFIRIX for the desensitisation treatment of highly sensitised adult kidney transplant patients with a positive crossmatch against an available deceased donor.