Clinical trial highlights efficacy of imlifidase for kidney transplant recipients

For kidney transplant recipients experiencing antibody-mediated rejection, the current standard of care involves removing donor-specific antibodies (DSAs) through plasmapheresis (PLEX)-;a procedure that removes antibodies from the plasma portion of the blood. Results from a recent clinical trial reveal that an investigational drug called imlifidase, which cleaves and inactivates the type of antibodies that include DSAs, is more effective than PLEX. The research will be presented at ASN Kidney Week 2024 October 23–27.

The phase 2 randomized, open-label, multi-center, multi-national trial included 30 patients with antibody-mediated rejection. Investigators assessed the maximum reduction of all DSA levels after starting either PLEX or imlifidase.

The median reduction of DSA was 97% for imlifidase compared with 42% for PLEX on day 5. The time to median maximum DSA depletion was 15 hours after a single dose of imlifidase compared with day 9 for a median of 6 PLEX sessions. 

These data further underscore imlifidase's consistent and efficient ability to reduce antibodies, which is important for patients who require safe and efficient reduction of DSA levels. We believe these data are important because it is the first head-to-head comparison of imlifidase versus frequently used standard of care treatment. The performance of imlifidase in this patient model was consistent with that observed in other indications and could be of relevance in other indications in which plasma exchange is used as the primary standard of care to address pathogenic antibodies." 

Stanley Jordan, MD, corresponding author of Cedars-Sinai Medical Center

Important objectives for future applications of imlifidase will focus on control of the antibody rebound process that is critical for long-term success in reducing DSAs and antibody rejection.

Study: "Imlifidase is superior to PLEX in rapidly and efficiently eliminating all IgGs including donor specific antibodies (DSAs) assessed in an antibody-mediated rejection (AMR) trial"