Closely held eGenesis and OrganOx announced that the FDA has cleared the IND application for EGEN-5784—a human-compatible, genetically engineered porcine liver—designed for use in combination with the OrganOx extracorporeal liver cross-circulation (ELC) system. The therapy targets patients with acute-on-chronic liver failure (ACLF) experiencing decompensated liver function in intensive care.
In November 2024, the companies entered into a collaboration to advance treatment for the estimated 35,000 patients hospitalized in the U.S. annually with ACLF. A first-in-human clinical trial will evaluate the novel perfusion system using a genetically engineered porcine liver for critically ill patients who have no transplant options.
According to eGenesis and OrganOx, four perfusions in decedent recipients have been completed to date as part of the PERFUSE-2 study, demonstrating the feasibility of using EGEN-5784 with the OrganOx ELC system to support patients with liver failure.
In a statement, Michael Curtis, Ph.D., CEO of eGenesis, said, “The FDA’s clearance of EGEN-5784 in combination with the OrganOx ELC system represents a significant advance towards fulfilling our mission to develop safe and effective human-compatible organs that have the potential to transform the treatment of organ failure and extend patients’ lives. In partnership with OrganOx, we are well positioned to evaluate the potential of this breakthrough technology in patients.”
Craig Marshall, CEO of OrganOx, commented, “This collaboration with eGenesis demonstrates a unique application of our platform metra technology, which can potentially save the lives of patients with acute-on-chronic liver failure who have limited treatment options and face high mortality rates.”
