ALOREN · Clinical Development of Advanced Therapeutic Medicinal Product for Acute Kidney Injury

Acute Kidney Injury (AKI) is a global health issue, costing over €300 billion annually, and has a seven-fold higher risk of developing chronic kidney disease (CKD), which is projected to be a leading cause of death by 2040. AKI affects up to 40% of patients undergoing cardiopulmonary bypass (CPB) surgery, with currently no effective treatment. We developed an innovative, immunomodulatory, scalable, placental stem cell-based Advanced Therapeutic Medicinal Product manufacturing platform to address the pressing need for effective treatment of CPB-AKI and prevention of CKD. Our clinical-grade bioprocessing platform and a lead compound, KELI-101, validated by positive preclinical data, demonstrated a breakthrough potential to significantly enhance survival, improve both functional and structural kidney recovery, reduce inflammation and prevent CKD. In addition, the multifactorial mode of action of KELI-101 enables its use to treat various inflammatory conditions. Implemented GMP-grade processes ensure consistent product quality and scalability, reinforcing KELI-101’s potential as a transformative therapy to address critical unmet medical needs globally. Our seasoned global expert team, combined with strong partnerships with global CROs and leading European clinical sites, enables us to efficiently drive an international Phase 1b/2 multicenter adaptive efficacy and safety trial for KELI-101. These efforts are aligned with the European Medicines Agency regulatory requirements, positioning us to successfully obtain marketing approval and bring this innovative therapy to the market. A strong business model approach with European medical centers and health systems, improved patient outcomes, decreased healthcare costs, reduced CKD prevalence, and multifunctional applicability of the platform will play a crucial role in strengthening Europe's autonomy.