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Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation
Robert Montgomery , MD, PhD, New York University Langone Health, said: "There have been few major breakthroughs in desensitization strategies in kidney transplantation for the last 30 years. The unmet need remains high for kidney transplant patients who are considered highly sensitized, with many remaining on the wait list with little to no hope of receiving a suitable match for transplantation. The result from the US ConfIdeS trial are highly encouraging and demonstrate the significant potential for imlifidase to transform standard of care for highly sensitized kidney transplant patients."
Patients who were randomized to receive imlifidase showed superior kidney function at 12 months of 51.5 mL/min/ 1.73m , compared to patients randomized to the control arm of 19.3 mL/min/ 1.73m . In the trial, the control arm allowed for a range of treatment options, including remaining on dialysis awaiting a more compatible organ offer, transplantation using off-label desensitization approaches, or transplantation with a compatible organ.
A key secondary outcome relating to dialysis independence at 12 months was also statistically significant in favor of imlifidase (p=0.0007). Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience.
Full results from the Phase 3 ConfIdeS trial will be submitted to a medical congress in 2026.
ConfIdeS is a pivotal Phase 3 open label, randomized, controlled trial of imlifidase in kidney transplantation. The trial evaluated kidney function at 12 months in 64 highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with a control arm. A total of 25 US sites participated in the trial and its primary endpoint is kidney graft function at 12 months, measured by mean eGFR (estimated glomerular filtration rate). The total trial duration is five years which includes a long-term follow-up as agreed to with the FDA as part of the accelerated approval pathway.
Imlifidase is conditionally approved in the European Union, Norway , Lichtenstein, Iceland and the UK under the brand name IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. IDEFIRIX® is also approved in Australia and Switzerland .
Information about the trial is available at ClinicalTrials.gov: NCT04935177
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Imlifidase is an antibody-cleaving enzyme originating from that specifically targets and cleaves immunoglobulin G (IgG) antibodies 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 Europe and is marketed under the trade name IDEFIRIX for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The use of IDEFIRIX should be reserved for patients who are unlikely to be transplanted under the available kidney allocation system, including prioritization programs for highly sensitized patients. IDEFIRIX was reviewed as part of the European Medicines Agency's (EMA) PRIority Medicines (PRIME) program, which supports medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options.
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. 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.
Kidney disease can progress to kidney failure or End-Stage Renal Disease (ESRD), identified when a patient's kidney function is less than 15%. ESRD poses a significant health burden, affecting nearly 2.5 million patients worldwide. 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 in the US and Europe waiting for a new kidney.
Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a next-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in Lund, Sweden , and has operations in Europe and the US The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com and follow us on LinkedIn.
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