The U.S. Food and Drug Administration has cleared eGenesis’ Investigational New Drug (IND) application to begin a clinical trial evaluating EGEN-2784, a genetically engineered porcine-derived kidney, in patients with end-stage kidney disease, according to the company.
The IND supports a Phase 1/2/3 study designed to assess the safety, tolerability and efficacy of EGEN-2784 at 24 weeks post-transplant in patients aged 50 or older, dependent on dialysis and on the kidney transplant waitlist. According to the company, this trial marks a significant step toward addressing the global organ shortage.
EGEN-2784 carries three classes of genetic modifications intended to enhance compatibility and long-term function in human recipients: elimination of three glycan antigens to avoid hyperacute rejection; insertion of seven human transgenes to modulate immune response, reduce inflammation, and improve coagulation and complement regulation; and inactivation of porcine endogenous retroviruses to enhance safety. The company claims it is the only firm developing organs with all three classes of edits.
In its ongoing multi-patient expanded access study, the first patient surpassed seven months of kidney function without dialysis, making them the longest-living recipient of a genetically engineered porcine organ. The second patient, transplanted in June, also no longer requires dialysis.
This advancement offers a promising new avenue for kidney failure patients amid chronic shortages in donor organs.
