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Pivotal Phase 3 study to commence in 2022 and is expected to enroll 50 patients across the
U.S. andEurope - Scientific advice on protocol obtained from both the
U.S. Food and Drug Administration (FDA) andEuropean Medicines Agency (EMA) with the aim of conducting a global study - Clinical Phase 2 data suggests that deactivation of autoantibodies by imlifidase could alter the course of this serious autoimmune disease
As previously communicated,
The pivotal Phase 3 clinical study will enroll 50 patients with anti-GBM disease across the
The recently completed investigator-initiated Phase 2 study by Professor Mårten Segelmark (GOOD-IDES-01 ClinicalTrials.gov Identifier: NCT03157037) showed 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. This positive outcome has been recognized for its significance, as it suggests that deactivation of autoantibodies by imlifidase could alter the course of an autoimmune disease.1
"Acceptance of our IND for this pivotal Phase 3 program in anti-GBM, a devastating disease, is an important milestone that will allow us to begin reaching out to patients soon," says
Imlifidase was granted Orphan Drug Designation in anti-GBM disease by both the FDA2 and the
--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 anti-GBM disease
Anti-GBM disease, also known as Goodpasture's disease, is a rare severe kidney disease affecting around 1.5 in a million people annually.4 The condition causes the immune system to mistakenly attack a specific part of the kidneys called the glomerular basement membrane (GBM) with IgG-antibodies, severely damaging the kidneys and in some cases the lungs. Many patients with anti-GBM disease lose kidney function and require chronic dialysis and kidney transplantation.5 In severe cases, anti-GBM disease may lead to death.
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 after administration. Imlifidase has conditional marketing approval in
About
References
1 Uhlin F. et al. JASN. 2022; https://jasn.asnjournals.org/content/early/2022/03/08/ASN.2021111460.
2
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4 Henderson R et al. Nephrology Dialysis Transplantation 2018. (33) 2: 196-202.
5 McAdoo S et al. Anti-GBM disease. Clin J Am Soc Nephrol 2017. 12: 1162-1172.
6
https://news.cision.com/hansa-biopharma-ab/r/hansa-biopharma-announces-u-s--fda-acceptance-of-investigational-new-drug--ind--application-for-phas,c3548037
https://mb.cision.com/Main/1219/3548037/1565456.pdf
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