The company has 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.
The results showed sustained positive outcomes out to 5 years in the majority of highly sensitized patients who received an imlifidase-enabled kidney transplant, states the company. 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 results from this study confirm the important role imlifidase plays in desensitization in kidney transplantation and further supports the clinical benefit of enabling HLA-incompatible kidney transplantation with imlifidase. Conditionally approved and marketed in Europe as Idefirix® (imlifidase), we believe it is a paradigm shifting treatment in kidney transplantation – one that will positively impact patient outcomes and ensure that highly sensitized patients waiting for a kidney have access to transplantation,” says Søren Tulstrup, President and CEO, Hansa Biopharma.
The 17-HMedIdeS-14 study
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.
Photo of Søren Tulstrup: Hansa Biopharma