FDA clears IND application for eGenesis EGEN-2784 clinical trial in end-stage kidney disease

eGenesis/EGEN-2784

The US FDA cleared eGenesis's IND application on September 8, 2025, authorizing a Phase 1/2/3 study (RESTORE) enrolling 33 patients age 50+ with end-stage kidney disease who are dialysis-dependent and on the transplant waiting list. The trial will evaluate safety, tolerability, and efficacy at 24 weeks post-transplant, with enrollment beginning in the first half of 2027.

• RESTORE trial will enroll 33 end-stage kidney disease patients age 50+, dialysis-dependent, waiting-listed.
• Primary endpoint is safety and efficacy at 24 weeks post-transplant.
• Clearance follows six months of successful expanded-access transplants establishing durability and feasibility.