Business
Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation
Hansa Biopharma AB, ("Hansa" or "the Company"), (Nasdaq Stockholm: HNSA), today announced positive topline results from the US Phase 3 ConfIdeS trial of imlifidase, evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) adult kidney transplant patients with positive crossmatch against a deceased donor, versus the control arm. The trial was well conducted, with patient retention in excess of 90%, and met the primary endpoint of kidney function at 12 months as measured by mean esti
About this update from Hansa Biopharma Ab
[{"type":"list","items":[{"val":[{"type":"text","content":"At 12 months, mean eGFR was 51.5 mL/min/1.73m2 in the imlifidase arm versus 19.3 mL/min/1.73m2 in the control arm with a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m2 ( p<0.0001)","length":225,"tagName":"p"}]},{"val":[{"type":"text","content":"Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience ","length":112,"tagName":"p"}]},{"val":[{"type":"text","content":"Submission of a Biologic License Application (BLA) under accelerated approval pathway planned for end of 2025 ","length":109,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":446,"olType":false},{"type":"text","content":"LUND, Sweden, Sept. 24, 2025 /PRNewswire/ -- Hansa Biopharma AB, ("Hansa" or "the Company"), (Nasdaq Stockholm: HNSA), today announced positive topline results from the US Phase 3 ConfIdeS trial of imlifidase, evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) adult kidney transplant patients with positive crossmatch against a deceased donor, versus the control arm. The trial was well conducted, with patient retention in excess of 90%, and met the primary endpoint of kidney function at 12 months as measured by mean estimated Glomerular Filtration Rate (eGFR) with a p-value of <0.0001. The Company plans to submit a BLA under the accelerated approval pathway to the US Food and Drug Administration (FDA) by the end of 2025.","length":772,"tagName":"p"},{"type":"text","content":"Renée Aguiar-Lucander, CEO, Hansa Biopharma said: "We are excited to share the data from the US ConfIdeS trial, which clearly shows the clinically meaningful benefit of imlifidase in kidney transplantation of highly sensitized patients, and the role it can play in shaping future standard of care. These results corroborate the existing clinical and real-world evidence of the use of imlifidase as an effective desensitization therapy in kidney transplantation. We look forward to sharing this body of data with the FDA in our mission to bring this medicine to these patients who today have very limited options. I would like to thank all the patients, their families, as well as the investigators and the site staff who continue to participate in the trial."","length":769,"tagName":"p"},{"type":...