-
Results of an investigator-initiated open-label Phase 2 study of imlifidase in patients with anti-glomerular basement membrane (anti-GBM) disease published in leading nephrology publication Journal of the
American Society of Nephrology (JASN).1 - Imlifidase rapidly and completely reduced pathogenic anti-GBM antibody levels to below reference range.
- At six months 67% of the included patients had functioning kidneys versus 18% in a historical control cohort.
- The publication recognises the study's significance in autoimmune diseases as it suggests that deactivation of autoantibodies could alter the course of an autoimmune disease, allowing restoration of kidney function. These results highlight the potential of imlifidase beyond kidney transplantation, paving the way for a Phase 3 study in anti-GBM, planned to begin this year.
The results show that kidney function at 6 months was significantly better than in previously published cohorts, without any safety concerns. Of the 15 patients included, 10 were dependent on dialysis at enrollment. At 6 months, a total of 67% (N=10) of the included patients were dialysis independent, which is significantly better than in the historical control cohort, where only 18% had functioning kidneys. All patients that were dialysis-independent at baseline remained so during the study.
"These are really exciting results, as this is the first time we have seen a study suggesting that the course of an acute autoimmune disease like anti-GBM disease can be changed by targetting the antibodies underpinning the immune response. The effects were such that half of patients that were on dialysis before the treatment had regained kidney function by the end of the trial, compared to less than 20% in the historical control group." says Coordinating Principle Investigator,
Anti-GBM disease is a rare and acute autoimmune condition which can lead to permanent kidney failure and even death. It is caused when the immune system mistakenly attacks a specific part of the kidneys called the glomerular basement membrane (GBM), damaging the kidneys and in some cases the lungs also. Prognosis for the condition is poor, particularly because its rarity can lead to delayed diagnosis in a situation where, given the disease's acute nature, prompt treatment is very important.
"The JASN publication not only brings hope to patients suffering from anti-GBM disease, but illustrates the potential of imlifidase beyond transplantation," says
The recently completed investigator-initiated Phase 2 study was sponsored by Professor Mårten Segelmark and Linköping University.
--- ENDS ---
For more information:
M: +46 (0) 709-298 269
E: klaus.sindahl@hansabiopharma.com
M: +46 (0) 768-198 326
E: katja.margell@hansabiopharma.com
Notes to Editors:
About imlifidase
Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets IgG and inhibits IgG-mediated immune response. It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours of administration. Imlifidase has conditional marketing approval in
Due to the pressing unmet needs in patients with this condition, imlifidase was granted orphan drug designation in anti-GBM disease by both the
About anti-glomerular basement membrane (anti-GBM) disease
Anti-GBM disease, also known as Goodpasture's disease, is a rare acute autoimmune disease affecting around one in one million people.4 The condition causes the immune system to mistakenly attack a specific part of the kidneys called the glomerular basement membrane (GBM), damaging the kidneys and in some cases the lungs also. Severe anti-GBM can be fatal, sometimes causing kidney failure and bleeding in the lungs.
About
References
1 Uhlin F. et al. JASN. 2022; https://jasn.asnjournals.org/content/early/2022/03/08/ASN.2021111460.
2 DeVrieze BW. et al. Goodpasture Syndrome. [Updated 2021
3
4 Greco A, et al. Autoimmunity Reviews. 2015;14(3):246-253.
https://news.cision.com/hansa-biopharma-ab/r/key-data-demonstrating-the-potential-of-hansa-biopharma-s-imlifidase-to-significantly-alter-course-o,c3521311
https://mb.cision.com/Main/1219/3521311/1546030.pdf
(c) 2022 Cision. All rights reserved., source