Hansa Biopharma announced results from an extended pooled analysis using data from the 17-HMedIdeS-14 study, an international long-term follow-up study of patients who have received a kidney transplant following desensitization with imlifidase, showing sustained positive outcomes out to 5 years in the majority of highly sensitized patients who received an imlifidase-enabled kidney transplant. After 5 years, the patient survival rate was 90% (three deaths occurring between six months and one year, and no deaths occurring between one and five years) and graft survival (death censored) was 82%, in line with outcomes seen at 3-years post-transplant. At five years, mean estimated glomerular filtration rate (eGFR) was 50 mL/min/m2.

eGFR is a measure of how well the kidneys are working in the body. The 17-HMedIdeS-14 study included patients who consented to long-term follow-up and had previously received an imlifidase-enabled transplant in Hansa's phase 2 studies. The 5-year extended pooled analysis is a continuation of the analysis at 3-years of crossmatch positive only patients published in the American Journal of Transplantation.

Hansa is continuing to analyze the data from 17-HMedIdeS-14 along with the extended pooled analysis and plans to share further data in 2024. Imlifidase is a promising new strategy for desensitization of transplant patients with donor-specific anti-HLA (Human Leukocyte Antigens) antibodies (DSAs). Highly sensitized patients have high levels of preformed antibodies that can damage the transplant.

Once they inactivated with imlifidase, there is a window of opportunity for the transplant to take place. By the time the body starts to synthesize new IgG, the patient will be receiving post-transplant immunosuppressive therapy to reduce the risk of organ rejection.