Hansa Biopharma, "Hansa" announced it has completed the enrolment of patients in the GOOD-IDES-02 trial, a global pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Anti-GBM is a rare, severe autoimmune condition affecting around 1.6 people per million annually.¹ Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. FDA and the European Medicines Agency (EMA). Enrolment completion was originally planned for 2025.

Søren Tulstrup, President and CEO, Hansa Biopharma said, "We are very pleased with the fast enrolment of all 50 patients in the GOOD-IDES-02 trial. 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."

Anti-GBM is Hansa Biopharma's most advanced program in the autoimmune space. GOOD-IDES-02 is an open label, multi-center Phase 3 trial involving over 40 centers across the US, UK, and EU. A total of 50 patients have been enrolled in the trial. In the trial, 25 patients were randomized to receive imlifidase in combination with standard of care (SoC), consisting of a combination of immunosuppressives, glucocorticoids, and plasma exchange, and 25 patients received only SoC. The primary objective of the study is to assess the superior effect on kidney function of imlifidase in combination with SoC versus SoC alone in the treatment of patients affected by severe anti-GBM disease. The performance of the treatment is assessed at 6 months through the evaluation of renal function as measured by estimated glomerular filtration rate (eGFR) and need of dialysis. In addition, the safety profile and efficacy on pulmonary symptoms and health related quality of life aspects are evaluated.

Hansa Biopharma, "Hansa" (Nasdaq Stockholm: HNSA) today announced it has completed the enrolment of patients in the GOOD-IDES-02 trial, a global pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Anti-GBM is a rare, severe autoimmune condition affecting around 1.6 people per million annually.¹ Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. FDA and the European Medicines Agency (EMA). Enrolment completion was originally planned for 2025.

Søren Tulstrup, President and CEO, Hansa Biopharma said, "We are very pleased with the fast enrolment of all 50 patients in the GOOD-IDES-02 trial. 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."

Anti-GBM is Hansa Biopharma's most advanced program in the autoimmune space. GOOD-IDES-02 is an open label, multi-center Phase 3 trial involving over 40 centers across the US, UK, and EU. A total of 50 patients have been enrolled in the trial. In the trial, 25 patients were randomized to receive imlifidase in combination with standard of care (SoC), consisting of a combination of immunosuppressives, glucocorticoids, and plasma exchange, and 25 patients received only SoC. The primary objective of the study is to assess the superior effect on kidney function of imlifidase in combination with SoC versus SoC alone in the treatment of patients affected by severe anti-GBM disease. The performance of the treatment is assessed at 6 months through the evaluation of renal function as measured by estimated glomerular filtration rate (eGFR) and need of dialysis. In addition, the safety profile and efficacy on pulmonary symptoms and health related quality of life aspects are evaluated.