Hansa Biopharma has announced the completion of recruitment and randomisation for its pivotal Phase III ConfIdeS trial of imlifidase in kidney transplantation, in the US.
The trial data is a pivotal step towards submitting a biologic licence application (BLA) to the US Food and Drug Administration (FDA) in the second half of 2025.
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The ConfIdeS trial is an open-label, randomised, controlled study. This aims to assess the efficacy of imlifidase in improving kidney function in highly sensitised kidney transplant patients.
The trial involves 64 patients with a cPRA of ≥99.9% and a positive crossmatch against a deceased donor.
It compares the use of imlifidase for desensitisation with the standard of care.
A total of 24 sites in the US are taking part in the trial, in which the primary endpoint is kidney graft function at 12 months, measured by estimated Glomerular Filtration Rate (eGFR).
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By GlobalDataImlifidase has received conditional marketing approval in Europe under the trade name IDEFIRIX for desensitisation treatment in highly sensitised adult kidney transplant patients.
An antibody-cleaving enzyme derived from Streptococcus pyogenes, Imlifidase targets and cleaves immunoglobulin G (IgG) antibodies, and inhibits IgG-mediated immune response.
Imlifidase’s ability to cleave these antibodies provides a window of opportunity for successful transplantation and subsequent immunosuppressive therapy to prevent organ rejection.
Hansa Biopharma president and CEO Søren Tulstrup said: “The randomisation of 64 patients in the ConfIdeS trial is an important step in bringing imlifidase to the US to help address the significant unmet need faced by highly sensitised kidney transplant patients.
“Our hope is that the ConfIdeS trial will help further validate the role that imlifidase may play as a desensitisation treatment that enables HLA-incompatible kidney transplantation.”
The efficacy and safety of imlifidase as a pre-transplant therapy to reduce donor-specific IgG was previously studied in four Phase II clinical trials.
Hansa Biopharma is committed to further substantiating the clinical evidence of imlifidase through additional studies, including an observational follow-up and a post-approval efficacy study.
