Veloxis Pharmaceuticals has served as a partner in the consortium since 2017
CARY, N.C., Oct. 14, 2022 /PRNewswire/ — Critical Path Institute (C-Path) announced October 13, 2022 that its Transplant Therapeutic Consortium (TTC), of which Veloxis Pharmaceuticals is a member, received a draft qualification opinion for the iBox Scoring System through the European Medicines Agency’s (EMA) qualification of novel methodologies for drug development. This significant qualification means that the iBox Scoring System, which supports the evaluation of novel immunosuppressive therapy (IST) applications with EMA, will soon be available to be used as a secondary efficacy endpoint in kidney transplant clinical trials.
The draft qualification opinion is going through a public consultation stage through Nov. 17, 2022. After the public consultation period, the iBox Scoring System will represent the first qualified endpoint for any transplant indication and, importantly, the scoring system – with or without biopsy – can be used to demonstrate the superiority of a new IST compared to the standard of care (SOC) at six months up to 24 months post-transplant in pivotal or exploratory drug therapeutic studies.
The iBox Scoring System is a composite biomarker that utilizes multiple clinically relevant patient features to fully reflect the heterogeneity of graft failure, including…
