FDA clears trial for pig kidney transplants
Biotech firm eGenesis has received clearance from the U.S. Food and Drug Administration to begin a Phase 1/2/3 clinical trial of EGEN-2784, a genetically engineered pig-derived kidney designed for human transplantation. The trial aims to evaluate the safety and efficacy of the organ at 24 weeks in patients aged 50 or older with end-stage kidney disease who are dialysis-dependent and on the transplant waitlist.
This milestone follows major developments in eGenesis’ ongoing Multi-Patient Expanded Access study. The first patient, Tim Andrews, 67, received an EGEN-2784 kidney in January and has now surpassed seven months post-transplant without needing dialysis — the longest known survival for a recipient of a genetically modified porcine organ.
A second patient, Bill Stewart, 54, underwent a successful transplant in June and was discharged from Massachusetts General Hospital after one week. He no longer requires dialysis, having previously undergone the procedure three times a week for over two years.
EGEN-2784 incorporates three classes of genetic modifications: removal of glycan antigens to prevent immune rejection, insertion of seven human genes to improve compatibility and inactivation of porcine endogenous retroviruses to enhance safety.
“This is a historic moment for xenotransplantation,” said Leonardo Riella, M.D., medical director for kidney transplantation at Massachusetts General Hospital. “To see a patient thriving off dialysis for over seven months with a genetically engineered pig kidney is nothing short of groundbreaking.”
The development comes as over 800,000 Americans face end-stage kidney disease, with limited access to donor kidneys and a five-year dialysis mortality rate exceeding 50%.
Read more: eGenesis
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