Pharma Focus Europe

Hansa Biopharma Successfully Completes Randomization in Key Phase 3 Trial for ConfIdeS in the United States

Saturday, June 01, 2024

Hansa Biopharma AB, a company listed on the NASDAQ Stockholm (symbol: HNSA), has announced the completion of recruitment and randomization for its US ConfIdeS trial. This trial is a pivotal Phase 3 study evaluating the use of imlifidase in kidney transplantation. It enrolled 64 patients and aims to provide data supporting a Biologic License Application (BLA) submission to the US Food and Drug Administration (FDA) by the second half of 2025 under the accelerated approval pathway.

Hansa Biopharma, highlighted the significance of this milestone. He stated, "The randomization of 64 patients in the ConfIdeS trial is a crucial step forward in bringing imlifidase to the US to address the urgent needs of highly sensitized kidney transplant patients. We anticipate that the results of the ConfIdeS trial will further validate the role of imlifidase as a desensitization treatment, enabling HLA-incompatible kidney transplantation. We eagerly await the data from this trial."

The ConfIdeS trial involves 64 highly sensitized (cPRA ≥99.9%) kidney transplant patients with a positive crossmatch against a deceased donor. It compares the desensitization using imlifidase with standard care. The trial, conducted across 24 sites in the US, has its primary endpoint as kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate).

Imlifidase, marketed in Europe under the trade name IDEFIRIX®, has received conditional marketing approval for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. Additionally, it is being investigated for other conditions such as anti-glomerular basement membrane (anti-GBM) disease and Guillain-Barré syndrome (GBS), as well as a pre-treatment for gene therapy in rare disease patients with pre-existing antibodies.

Highly sensitized patients have pre-formed antibodies called donor-specific antibodies (DSAs) with broad reactivity against human leukocyte antigens (HLAs), which can lead to tissue damage and transplant rejection. These patients face challenges in finding compatible donor organs and spend prolonged periods on transplant waiting lists, with increased mortality risks. They represent approximately 10-15% of patients on transplant waiting lists in the US and Europe.

Imlifidase, derived from Streptococcus pyogenes, specifically targets and cleaves immunoglobulin G (IgG) antibodies, inhibiting IgG-mediated immune responses. Its rapid onset of action allows for the cleavage and inhibition of IgG antibodies within hours after administration. The use of IDEFIRIX is recommended for highly sensitized patients unlikely to receive transplants through the existing kidney allocation system, including prioritization programs for highly sensitized patients. The efficacy and safety of imlifidase have been demonstrated in four phase 2 clinical trials, with ongoing data collection for further assessment.

Kidney failure, or End-Stage Renal Disease (ESRD), affects nearly 2.5 million patients worldwide. A kidney transplant is the preferred treatment for eligible patients with ESRD due to its associated survival and quality of life benefits compared to long-term dialysis. Currently, there are approximately 170,000 kidney patients on transplant waiting lists across the US, European Union, and United Kingdom.



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