AION Healthspan, Inc. has launched enrollment for a groundbreaking Phase I/II clinical trial of REJUVXL, its proprietary cell therapy targeting Chronic Kidney Disease (CKD). The trial, which received FDA clearance under an Investigational New Drug application, focuses on patients with Stage 3 CKD, including those with Diabetic Nephropathy.
Novel Mechanism Targets Multiple Disease Pathways
REJUVXL represents a significant advancement in CKD treatment by simultaneously addressing multiple disease mechanisms. The therapy targets inflammation, fibrosis, immunity, and aging at the cellular level, aiming to promote tissue regeneration and angiogenesis while modulating immune response.
Dr. Yelena Drexler, Principal Investigator for the trial, emphasizes the therapy's potential impact: "If successful, REJUVXL has the potential to transform the landscape of chronic kidney disease treatment. The objective of REJUVXL is to target the underlying causes of CKD—chronic inflammation and fibrosis—while promoting tissue repair and regeneration."
Significant Market Need and Disease Burden
The therapy addresses a substantial medical need, with CKD affecting one in three adults with diabetes and 38% of individuals over 65. This translates to more than 110 million people across the U.S. and Europe struggling with the condition. Current treatment options, while helpful in managing symptoms, fail to halt or reverse disease progression.
Dr. Alessia Fornoni, nephrologist and Scientific Advisory Board member at AION Healthspan, notes: "At a time when the compound annual growth rate for kidney diseases has reached that of cancer, REJUVXL is uniquely positioned toward a successful clinical development."
Innovative Treatment Approach
REJUVXL's development represents a significant advance in cell therapy. The treatment utilizes cells derived from perinatal tissues, which are typically discarded after healthy births. This approach circumvents ethical concerns associated with embryonic or fetal cell use while offering several practical advantages:
- Administration via simple IV infusion
- No requirement for immunosuppressive drugs
- Capability for large-batch production
Current Treatment Landscape
The existing CKD treatment paradigm relies heavily on symptom management through various drug classes:
- ACE inhibitors and ARBs for blood pressure control
- Diuretics for fluid retention
- Calcium channel blockers
- Mineralocorticoid receptor antagonists
- Kerendia (finerenone) for additional protection
While these medications help manage symptoms and slow disease progression, they don't address the fundamental causes of kidney damage. REJUVXL's approach of targeting underlying disease mechanisms could potentially offer a more comprehensive solution for CKD patients.
The University of Miami Health System-based trial (NCT06721143) will evaluate REJUVXL's safety, tolerability, and early efficacy signals. If successful, this therapy could significantly reduce the need for dialysis and kidney transplants, marking a pivotal advancement in CKD treatment.
