Hansa Biopharma Completes Randomization in Pivotal Phase 3 US ConfIdeS Trial
Søren Tulstrup, President and CEO,
The ConfIdeS trial is evaluating kidney function in 64 highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care. A total of 24 US sites are participating in the trial and its primary endpoint is kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate).
Imlifidase has been granted conditional marketing approval in
This is information that
Contacts for more information:
Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com
Stephanie Kenney, VP Global Corporate Affairs
media@hansabiopharma.com
Notes to editors
About highly sensitized patients
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.1 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.2,3 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.2,3 Across the
About IDEFIRIX® (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.6 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration.
Imlifidase has conditional marketing approval in
Imlifidase is an effective strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs).7 Highly sensitized patients have high levels of these preformed antibodies that can bind to the donor organ and damage the transplant.8 Once they are 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.
The efficacy and safety of imlifidase as a pre-transplant treatment to reduce donor-specific IgG was studied in four phase 2 open-label, single-arm, six-month clinical trials.7,9-11 Hansa is collecting further clinical evidence and will submit additional efficacy and safety data based on one observational follow-up study and one post-approval efficacy study.
Full product information can be accessed via the initial Summary of Product Characteristics found here.
About kidney failure
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%.12 ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide.12 A kidney transplant is the treatment of choice for suitable patients with ESRD because it offers improved survival and quality of life benefits, and is cost savings compared to long-term dialysis. There are approximately 170,000 kidney patients on transplant waiting lists across the
About
©2024 Hansa Biopharma.
References
- 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 RR, et al. The mode of sensitization and its influence on allograft outcomes in highly sensitized kidney transplant recipients. Nephrol Dial Transplant. 2016 Oct;31(10):1746-53. doi: 10.1093/ndt/gfw099.
- Lonze BE, et al. IdeS (Imlifidase): A Novel Agent That Cleaves Human IgG and Permits Successful Kidney Transplantation Across High-strength Donor-specific Antibody. Ann Surg. 2018 Sep;268(3):488-496. doi: 10.1097/
- OPTN/SRTR 2022 Annual Data Report. HHS/HRSA; 2024. Accessed [
May 2024 ]. http://srtr.transplant.hrsa.gov/annual_reports/Default.aspx - 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. IgG Endopeptidase in Highly Sensitized Patients Undergoing Transplantation. N Engl J Med 2017;377:442-453. DOI: 10.1056/NEJMoa16125
- Manook M, et al. Post-listing survival for highly sensitised patients on the
UK kidney transplant waiting list: a matched cohort analysis.Lancet . 2017 Feb 18;389(10070):727-734. doi: 10.1016/S0140-6736(16)31595-1. - Winstedt L, et al. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. PMID: 26177518; PMCID: PMC4503742.
- Lorant T, et al. Safety, immunogenicity, pharmacokinetics, and efficacy of degradation of anti-HLA antibodies by IdeS (imlifidase) in chronic kidney disease patients. Am J Transplant. 2018 Nov;18(11):2752-2762. doi: 10.1111/ajt.14733.
- Jordan SC, et al. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021
Aug 1 ;105(8):1808-1817. doi: 10.1097/TP.0000000000003496 -
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 2022. International figures on donation and transplantation. Available at: Newsletter Transplant – latest edition | Freepub (edqm.eu) [Accessed May 2024].
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