Søren Tulstrup, President and CEO,
The 17-HMedIdeS-14 study included patients who consented to long-term follow-up and had previously received an imlifidase-enabled transplant in
Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs).11 Highly sensitized patients have high levels of preformed antibodies that can damage the transplant.12 Once they inactivated with imlifidase, there is a window of opportunity for the transplant to take place. By the time the body starts to synthesize new IgG, the patient will be receiving post-transplant immunosuppressive therapy to reduce the risk of organ rejection.
--- ENDS ---
Contacts for more information:
M: +46 (0) 709 298 269
E: klaus.sindahl@hansabiopharma.com
M: +1 (484) 319 2802
E: stephanie.kenney@hansabiopharma.com
Imlifidase
Imlifidase is an antibody-cleaving enzyme originating from Streptococcus pyogenes that specifically targets and cleaves immunoglobulin G (IgG) antibodies and inhibits IgG-mediated immune response.10 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.
Imlifidase is conditionally approved in
HMedIdes Clinical Trial Program
17-HMedIdeS-14 is part of the HMedIdeS clinical program for imlifidase. The program includes four global phase 2 trials (13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 and 15-HMedIdeS-06), one US open-label phase 3 trial (ConfIdeS), a long-term follow up study (17-HMedIdeS-14) and a post-authorization efficacy and safety study in
About kidney failure and highly sensitized patients
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.14 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.15 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and has cost savings compared to long-term dialysis. There are approximately 80,000 kidney patients on transplant waiting lists across the
Highly sensitized patients have pre-formed antibodies called donor specific antibodies (DSAs) with a broad reactivity against human leukocyte antigens (HLAs), which can cause tissue damage and potentially transplant rejection.4 The presence of DSAs means that highly sensitized patients tend to have limited or no access to transplant, as finding a compatible donor organ can be particularly challenging.6,7 The complexity of their immunological profile means that highly sensitized patients spend longer time than average on transplant waiting lists, with evidence showing that this longer time waiting for a suitable donor relates to an increased mortality risk.6,7 Across the
About
Full product information can be accessed via the initial Summary of Product Characteristics found here.
References
- Trial NCT03611621. Available at https://clinicaltrials.gov/study/NCT03611621?rank=1&limit=10&intr=imlifidase%20&aggFilters=status:com
- Kjellman C et al. Am J Transplantation 2021 Dec;21(12):3907-3918.
American Kidney Fund . All About the Kidneys. https://www.kidneyfund.org/all-about-kidneys/tests/blood-test-egfr#:~:text=eGFR%20(estimated%20glomerular%20filtration%20rate)%20is%20a%20measure%20of%20how,well%20your%20kidneys%20are%20working. AccessedOctober 2023 .- Poggio E et al. Am J Transplant. 2021 Aug;21(8):2824-2832.
-
Eurostam Report (A
Europe -wide strategy to enhance transplantation of highly sensitized patients on the basis of acceptable HLA mismatches.) Available at https://cordis.europa.eu/project/id/305385/reporting. - Redfield R, et al. Nephrol Dial Transplant 2016; 31:1746-1753
- Lonze BE, et al. Ann Surg 2018; 268(3):488-496
- EDQM. (2020). International figures on donation and Transplantation 2019
- SRTR Database and individual assessments of allocation systems
European Medicines Agency . Idefirix® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf.- Jordan SC, et al. N Engl J Med 2017; 377(5):442-453.
-
Manook M, et al.
Lancet 2017; 389(10070):727-734. - Winstedt L, et al. PLoS One 2015; 10(7): e0132011
- Lorant T, et al. Am J Transplant 2018;18(11):2752-2762.
-
Jordan SC, et al. Transplantation
October 21 2020 - volume online first issue NIH (2018). What is kidney failure? Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure/what-is-kidney-failure.- Newsletter Transplant 2020. pp 58-60.
https://news.cision.com/hansa-biopharma-ab/r/imlifidase-demonstrated-90--patient-survival-and-82--graft-survival-at-five-years-in-extended-pooled,c3854683
https://mb.cision.com/Main/1219/3854683/2362116.pdf
(c) 2023 Cision. All rights reserved., source