Update on ConfIdeS phase III trial of imlifidase in highly sensitized kidney transplant patients – Hansa Biopharma

Hansa Biopharma announced randomization for the US ConfIdeS trial is expected to conclude in mid-2024. The ConfIdeS trial is an open-label, controlled, randomized Phase III trial evaluating 12-month kidney function in highly sensitized (cPRA greater than 99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care. Hansa plans to submit a Biologics License Application (BLA) under the accelerated approval pathway to the FDA in 2025.

To accelerate randomization, Hansa has increased overall site activation up to 25 sites, continued enrollment beyond the targeted 64 patients, and amended the trial protocol to potentially facilitate a broader set of donors for organ allocation. Currently, 87 patients are enrolled in the trial at 16 activated trial sites with nine additional sites being initiated.

Søren Tulstrup, President and CEO, Hansa Biopharma said, “What we now know is that identifying and screening patients for this trial can take anywhere from one week to several months based on patient, donor and site-specific factors including overall patient health and proximity to the site. And, unlike other trials that can progress once patients meet certain criteria, this trial is largely dependent on allocation of suitable organs to consented patients. Organ allocation in the U.S. is managed by an independent third party. With this in mind, randomization is taking weeks and even months in most instances. We appreciate the ongoing commitment and dedication of participating trial centers and are committed to advancing this important clinical trial.”

The ConfIdeS trial is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. The study’s primary endpoint is kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate) in highly sensitized kidney patients following an imlifidase-enabled kidney transplant. The trial design requires randomization of 64 highly sensitized kidney transplant patients with a cPRA of greater than 99.9%, representing a subset of very highly sensitized patients.