Hansa Biopharma has reported positive top-line results from its Phase III ConfideS trial of imlifidase, an investigational enzyme therapy for kidney transplant patients.
The study, which enrolled 64 adults who had undergone kidney transplantation, compared patients treated with imlifidase to those receiving a range of control options, including dialysis while awaiting a more compatible organ, transplantation with off-label desensitization approaches, or transplantation with a compatible organ. Patients were randomly assigned to either the treatment or control arm.
At 12 months, imlifidase treatment delivered “statistically significant and clinically meaningful” improvements in kidney function, as measured by mean estimated glomerular filtration rate. The trial also found that significantly more patients in the imlifidase group were no longer dependent on dialysis at that time point.
Richard Philipson, M.D., Hansa Biopharma’s chief medical officer, stated that the study met its primary endpoint, noting that imlifidase was well-tolerated with a low incidence of infusion reactions. Other side effects were consistent with the transplant population and generally considered unrelated to treatment.
Secondary outcomes included graft and patient survival, which did not reach statistical significance at 12 months. William Blair analysts wrote that they did not expect a survival benefit to be observed at this stage, emphasizing that longer follow-up will be required to assess the impact.
Episodes of delayed graft function were detected, but were balanced between the treatment and control arms. Antibody-mediated rejections did not lead to transplant losses. William Blair noted that rates of delayed graft function and antibody-mediated rejection will be important in evaluating the therapy’s potential long-term benefit.
On Thursday’s call with analysts, Hansa Biopharma executives highlighted that kidney transplantation is generally preferred over dialysis for patients with end-stage renal disease. They noted that highly sensitized patients face particular difficulty in securing a match because of high antibody levels. Imlifidase was developed to cleave Immunoglobulin G antibodies within hours, aiming to reduce the likelihood of organ rejection.
Renée Aguiar-Lucander, Hansa’s chief executive, said the company plans to file a Biologics License Application with the U.S. Food and Drug Administration by the end of the year and intends to seek an accelerated review. She added that a decision could come in the third quarter of 2026.
Maria Törnsén, Hansa Biopharma’s chief operating officer and U.S. chief, said that highly sensitized patients represent 10% to 15% of the approximately 100,000 people on the U.S. kidney transplant list. She noted that the company has already engaged with about a quarter of U.S. transplant centers through its clinical trials and outlined plans to recruit a field team of 20 account managers. “The unmet needs in the U.S. kidney transplant market are significant,” she said.
Analysts at William Blair estimated that imlifidase could reach peak sales of $306 million. They wrote that “this is a key inflection for Hansa, as it will unlock the large U.S. kidney transplant market opportunity,” projecting potential FDA approval in the second half of 2026.
Imlifidase is administered intravenously and derived from IgG-degrading enzymes in Streptococcus pyogenes. It works by cleaving IgG antibodies to suppress immune activity that can lead to transplant rejection. The therapy was approved in August 2020 in the European Union under the brand name Idefirix and has conditional approvals in several other countries.
This success for Hansa Biopharma in Phase III is more than a clinical win—Hansa Biopharma will reshape how highly sensitized patients are managed globally. If the BLA submission is accepted, imlifidase could become a standard desensitization option for patients who otherwise face long wait times or inability to receive a transplant.
Moreover, Hansa Biopharma must scale manufacturing, supply chain logistics, and train U.S. transplant centers on this novel approach. Commercial execution will matter as much as clinical efficacy.
