Hansa Biopharma Completes Global Phase 3 Trial Enrolment for Imlifidase in Anti-GBM Disease

Hansa Biopharma, based in Lund, Sweden, has successfully completed the enrolment phase for the GOOD-IDES-02 trial, a pivotal Phase 3 study focusing on anti-glomerular basement membrane (anti-GBM) disease, a severe autoimmune condition. Anti-GBM disease, also known as Goodpasture disease, affects approximately 1.6 people per million annually. The condition often leads to significant kidney damage, with a majority of patients experiencing kidney failure and requiring long-term dialysis.

Imlifidase, the drug being investigated in this trial, has received orphan drug designation from both the U.S. FDA and the European Medicines Agency (EMA) for the treatment of anti-GBM disease. Originally, the enrolment completion was projected for 2025; however, it has been achieved ahead of schedule.

Søren Tulstrup, President and CEO of Hansa Biopharma, expressed satisfaction with the rapid enrolment of all 50 patients. He noted that this achievement is a crucial step toward understanding the potential of imlifidase to meet the significant unmet medical needs in anti-GBM treatment. He emphasized that most patients with anti-GBM lose kidney function, with two-thirds of them requiring long-term dialysis. Tulstrup shared optimism regarding the future updates and the study's outcome, expected to be disclosed in 2025.

The GOOD-IDES-02 trial is Hansa Biopharma's leading initiative in the autoimmune disease area. It is an open-label, multi-center study conducted across more than 40 centers in the US, UK, and EU. The trial enrolled 50 patients, who were divided into two groups: one receiving imlifidase in combination with the standard of care (SoC), and the other receiving only SoC. The standard treatment includes immunosuppressives, glucocorticoids, and plasma exchange.

The primary goal of the study is to assess the improvement in kidney function when imlifidase is combined with SoC, compared to SoC alone. The effectiveness of the treatment will be measured through renal function evaluations at six months, using estimated glomerular filtration rate (eGFR) and the need for dialysis. Additionally, the trial will monitor the safety profile and its impact on pulmonary symptoms and the patients' quality of life.

More details about the trial can be found on ClinicalTrials.gov under the identifier NCT05679401.

Anti-GBM disease is a rare autoimmune condition in which the immune system erroneously targets the glomerular basement membrane in the kidneys, leading to an acute immune response that damages the kidneys and often the lungs. The majority of affected individuals suffer kidney failure, necessitating long-term dialysis, and some may experience severe lung complications. In some cases, the disease can be fatal during its acute phase.

Imlifidase, an enzyme derived from Streptococcus pyogenes, targets and cleaves IgG antibodies, thereby inhibiting the IgG-mediated immune response within hours of administration. It has received conditional marketing approval in Europe under the trade name IDEFIRIX®, specifically for desensitizing highly sensitized adult kidney transplant patients.

Hansa Biopharma is a commercial-stage biopharmaceutical company dedicated to developing and commercializing novel treatments for rare immunological conditions. Their work centers on their proprietary IgG-cleaving enzyme technology platform, addressing unmet medical needs in areas such as transplantation, autoimmune diseases, gene therapy, and cancer. Hansa Biopharma operates in Europe and the U.S., and is listed on Nasdaq Stockholm under the ticker HNSA. Data from the trial is expected to be shared in 2025.