#Sweden #Lund #Hansa Biopharma #imlifidase #Anti-GBM

Hansa Biopharma Completes Patient Enrollment in Global Phase 3 Trial

Hansa Biopharma AB, known for its innovative biopharmaceutical approaches, has proudly announced the completion of patient enrollment in its pivotal Phase 3 clinical trial named GOOD-IDES-02. This trial focuses on imlifidase, an investigational drug aimed at addressing the unmet medical needs of patients suffering from anti-glomerular basement membrane disease (anti-GBM disease).

Understanding Anti-GBM Disease

Anti-GBM disease is a rare and serious autoimmune condition, affecting approximately 1.6 individuals per million each year. In this disorder, the immune system inaccurately targets an intrinsic antigen within the glomerular basement membrane, leading to kidney impairment and even respiratory complications in half of the affected patients. Many individuals with this condition ultimately require long-term dialysis due to kidney failure. Given its severity, the development of effective treatments is critical.

The GOOD-IDES-02 Trial

The GOOD-IDES-02 trial is an open-label Phase 3 study conducted across more than 40 sites in the United States, the United Kingdom, and Europe. It enrolled 50 patients, of which 25 received imlifidase alongside standard treatments that include immunosuppressives, glucocorticoids, and plasma exchange. The remaining 25 participants were administered only the standard of care. The primary goal of the trial is to evaluate the effectiveness of imlifidase in improving kidney function compared to standard treatments alone over a six-month period.

Søren Tulstrup, President and CEO of Hansa Biopharma, expressed satisfaction with the swift patient enrollment process, highlighting its importance for addressing the significant medical needs of those suffering from anti-GBM disease. He noted that while the original goal was to complete enrollment by 2025, the collaboration between various stakeholders has expedited this outcome. The necessity of this research is underscored by the fact that a vast majority of patients with anti-GBM disease face a decline in kidney function, with two-thirds experiencing kidney failure necessitating dialysis.

Looking Ahead

Hansa Biopharma plans to share the outcomes of this trial in 2025. Alongside assessing kidney function using estimated glomerular filtration rate (eGFR), the study will also examine the safety profile of the treatment as well as its effects on pulmonary symptoms and quality of life for participants.

Insights into Imlifidase

Imlifidase is an innovative, antibody-cleaving enzyme derived from Streptococcus pyogenes. Its unique mechanism of action involves targeted cleavage of IgG antibodies, which mitigates their immune response within hours of treatment. The drug has received orphan drug designation in both the U.S. and Europe, underscoring its potential to provide solutions for rare diseases like anti-GBM.

Additionally, imlifidase holds conditional marketing approval in Europe under the name IDEFIRIX, specifically for the desensitization of highly sensitized kidney transplant patients. Hansa Biopharma is further exploring the use of imlifidase in various autoimmune diseases and hopes to reveal more about its efficacy in trials related to conditions like Guillain-Barré Syndrome.

About Hansa Biopharma

Headquartered in Lund, Sweden, Hansa Biopharma is at the forefront of developing transformative therapies for rare immunological conditions. With a focus on innovating medical treatments that address significant gaps in patient care, Hansa's proprietary IgG-cleaving enzyme technology is set to alter the landscape of treatment for patients in dire need of effective solutions. The company documents its ongoing commitment to research and development, aiming to expand its footprint in transplantation and autoimmune disease therapies.