The Transplant Therapeutics Consortium (TTC), of which the European Society of Organ Transplantation (ESOT) is a proud member, has today announced that the iBox Scoring System has received a qualification opinion as a novel secondary efficacy endpoint for kidney transplant through the European Medicine Agency’s (EMA) qualification of novel methodologies for drug development.
The iBox Scoring System is a composite biomarker based on the integration of multiple features reflecting both the renal graft function and the immunologic response of the recipient (with or without direct assessment of allograft histopathology). Initially developed by the Paris Transplant Group as a patient-level decision-making tool, the iBox Scoring System, thanks to the joint efforts of the international partners of the TTC, is now approved as a novel secondary efficacy endpoint for future clinical trials aiming at demonstrating the superiority of a novel immunosuppressive therapy (IST) compared to the standard of care (SOC) from six to 24 months post-kidney transplant in pivotal or exploratory drug therapeutic studies.
This landmark decision by the EMA marks the qualification of the first endpoint for any transplant indication and represents an important step in addressing a major area of unmet need for kidney transplantation recipients – long-term graft survival. While short-term graft survival in kidney transplantation has seen continuous improvement in recent years, long-term graft survival remains historically unchanged. The qualification of the iBox Scoring System, which can be used at early time-points post-transplantation to accurately predict long-term graft survival, represents another step along the road paved by ESOT (Transpl Int. 2022 May 20;35:10142.doi: 10.3389/ti.2021.10142. eCollection 2022) to moves the transplantation community closer to unlocking new therapies that can accelerate positive change in this area and better the lives of transplant recipients.
“This is an important landmark in transplantation that marks a transition towards personalised patient prediction outcomes that will influence not only long-term outcomes and organ allocation but also the conduct of clinical trials and their measurable endpoints.” Gabriel Oniscu, ESOT President-elect
To help improve future clinical trial efficiency and aid sponsors in designing trials utilising the iBox Scoring System as an endpoint, TTC has developed a publicly available sample size calculator using iBox scores. The calculator enables sponsors to apply various inclusion/exclusion criteria and other specifications to help enhance understanding of how group differences in iBox parameters translate to a difference in iBox scores.
In 2017, TTC was co-founded by the Critical Path Institute (C-Path), the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS) with a mission to accelerate the medical product development process for transplantation. In 2022, ESOT joined TTC to support the use of the iBox Scoring System as a secondary endpoint in future trials of kidney transplantation, in line with the broad initiative that ESOT initiated with EMA to redefining the risk stratification and endpoints for clinical trials in kidney transplantation in 2017 (REF Transpl Int. 2022 May 20;35:10142.
doi: 10.3389/ti.2021.10142. eCollection 2022.).
In addition, ESOT is also supporting TTC’s next planned regulatory milestone: the regulatory endorsement of the iBox Scoring System as a reasonably likely surrogate endpoint by the FDA, to whom the Qualification Plan has been submitted and is under review.
The qualification opinion can be found on the EMA website or the TTC website here.
