Hansa Biopharma AB has announced positive topline results from the European 20-HMedIdeS-19 Post Authorization Efficacy Study (PAES), an open-label confirmatory study investigating one-year graft failure-free survival and patient survival in highly sensitised patients who have undergone HLA-incompatible kidney transplantation following desensitisation treatment with Idefirix (imlifidase).
Renée Aguiar-Lucander, CEO of Hansa Biopharma, said: “These positive results represent a significant milestone for Idefirix and for Hansa. The one-year graft failure-free survival observed in this highly sensitized patient population confirms the clinical benefit of Idefirix and demonstrates expected efficacy outcomes supported by a safety profile consistent with prior clinical experience. With this post-authorization requirement fulfilled, we look forward to submitting an application for conversion to full marketing authorization to the EMA by the end of 2026.”
Tomas Lorant, associate professor, transplant surgeon at Akademiska Hospital, Uppsala University and the coordinating investigator for the trial, said: “Imlifidase is transforming transplantation care for highly sensitized patients in Europe, by enabling kidney transplantation for patients who would otherwise have remained on the transplant waiting list for an extended, often indefinite period. The PAES study results confirm the key role of imlifidase in allowing us to treat those kidney transplant patients with the highest unmet need.”
Imlifidase is conditionally approved in the European Union under the brand name Idefirix as a desensitisation treatment for highly sensitised adult patients prior to kidney transplantation from deceased donors. As part of the conditional marketing authorisation, the European Medicines Agency (EMA) requested a post-authorisation efficacy study (PAES) for Idefirix.
The first patient was enrolled in May 2022. Twenty-two transplant centres in 11 countries in the EU and the UK participated in the study. Fifty-one patients were enrolled and treated with Idefirix in the study.
The primary objective of the PAES was met, with 90% of highly sensitized kidney transplant patients achieving one-year graft failure-free survival following Idefirix pre-treatment to convert a positive crossmatch against a deceased donor to negative prior to transplantation.
Secondary objectives included evaluation of renal function one year after transplantation, assessed by estimated glomerular filtration rate (eGFR), as well as patient and graft survival at one year.
In patients treated with Idefirix, at one year, mean estimated glomerular filtration rate (eGFR) was 52.4 mL/min/1.73 m², graft survival was 92%, and patient survival was 98%.
The study was well conducted with patient retention greater than 94%. Idefirix was generally well tolerated, with a safety profile consistent with previous clinical trial experience.
The obligation to complete a post-authorisation efficacy study, as defined under the conditional marketing authorisation, is now considered fulfilled and an application for conversion to full marketing authorisation to EMA is planned to be submitted by the end of 2026.
Full results from the PAES will be submitted for presentation at an upcoming medical congress.