Hansa Biopharma's Imlifidase Achieves Phase III Success, Eyes FDA Approval for Kidney Transplants

Hansa Biopharma, a Swedish biopharmaceutical company, has reported positive top-line results from its U.S. Phase III ConfideS trial of imlifidase, an antibody-cleaving enzyme designed to improve kidney transplant outcomes in highly sensitized patients. The success of this late-stage study marks a significant milestone for the company as it prepares to file for FDA approval, potentially unlocking a substantial market opportunity in the United States.

Phase III Trial Results and Clinical Impact

The ConfideS trial, which enrolled 64 adults who had undergone kidney transplantation, demonstrated statistically significant and clinically meaningful kidney function benefits at 12 months. Patients treated with imlifidase showed improved mean estimated glomerular filtration rate (eGFR) compared to the control arm. Additionally, a significantly higher proportion of imlifidase-treated patients were no longer dependent on dialysis at the one-year mark.

Dr. Richard Philipson, Hansa's Chief Medical Officer, noted that the drug was well-tolerated with a low incidence of infusion reactions. Other side effects were generally consistent with those typically observed in kidney transplant populations and were considered unrelated to imlifidase treatment.

While the primary endpoint was met, some key secondary outcomes, including graft and patient survival, did not reach statistical significance. Analysts at William Blair suggested that longer follow-up may be needed to gauge any significant impact of treatment on these measures.

Regulatory Pathway and Market Potential

Hansa Biopharma plans to file a Biologics License Application (BLA) for imlifidase with the FDA by the end of the year. The company is aiming for an accelerated review process, which could lead to a potential approval decision in the third quarter of 2026.

Ren??e Aguiar-Lucander, Hansa's CEO, emphasized the significance of this development, stating, "This is a key inflection for Hansa, as it will unlock the large U.S. kidney transplant market opportunity." Analysts at William Blair estimate peak sales for imlifidase could reach $306 million.

The unmet need in the U.S. kidney transplant market is substantial, with highly sensitized patients comprising about 10% to 15% of the approximately 100,000 individuals on the kidney transplant waiting list. Maria T??rns??n, Hansa's Chief Operating Officer and U.S. Chief, highlighted the company's focus on the roughly 200 centers offering kidney transplants in the United States, noting that Hansa has already worked with about 25% of the U.S. transplant market through its clinical trials.

Imlifidase: Mechanism of Action and Global Status

Imlifidase is a protease extracted from IgG-degrading enzymes found in Streptococcus pyogenes bacteria. Administered intravenously, it specifically targets and cleaves IgG antibodies, suppressing the body's ability to reject kidney transplants. This mechanism is particularly beneficial for highly sensitized patients who produce high levels of antibodies that can attack foreign tissues, making it difficult to find compatible donor organs.

The therapy has already received conditional approval in the European Union and several other countries, where it is marketed under the brand name Idefirix. The EU approval, granted in August 2020, paved the way for its use in facilitating kidney transplants for certain patients with end-stage renal disease.

As Hansa Biopharma prepares for a potential U.S. launch, the company plans to recruit a field team of about 20 account managers to support the commercialization efforts. With a strong foundation built through clinical trials and a targeted approach to key transplant centers, Hansa expresses confidence in its strategy for a successful U.S. market entry, pending FDA approval.