OrganOx, a medical technology company developing innovative solutions for organ preservation and eGenesis, a biotechnology company developing human-compatible organs for patients with organ failure, announced an exclusive clinical co-development agreement to advance a liver support system to facilitate liver recovery in the acute setting. OrganOx’s normothermic machine perfusion (NMP) technology will be combined with eGenesis’ human-compatible, genetically engineered porcine livers to treat patients with liver failure.
The companies will focus on the estimated 35,000 patients in the United States hospitalised each year for acute or acute-on-chronic liver failure. The efficacy of existing liver support options is limited, and patients in liver failure face mortality rates as high as 50 percent. For some patients, utilising a human compatible, genetically engineered porcine liver to support the function of a patient’s decompensated liver may provide time for the recovery of the patient’s native liver or time to obtain a liver transplant.
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Based on positive clinical data demonstrated in these initial patient populations, the companies may explore the use of this system for the over 300,000 additional patients admitted annually to hospital in the United States in the acute setting with other forms of liver failure.
Earlier this year, the companies announced a proof of concept demonstration of the approach and have now successfully completed three such experiments as part of the PERFUSE-2 study4, evaluating the feasibility of using this perfusion system to support patients suffering from liver failure. The perfusions were performed using the eGenesis liver, EGEN-5784, connected to the OrganOx extracorporeal liver cross-circulation (ELC) system. eGenesis and OrganOx anticipate submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in 2025 to initiate a Phase 1 clinical study.
“Our expanded partnership, and now exclusive co-development agreement with eGenesis, not only strengthens our relationship but also demonstrates our confidence in the technology we’re jointly advancing,” said Craig Marshall, CEO of OrganOx. “This co-development further exemplifies our mission to improve treatment options for patients with organ failure.”
The OrganOx ELC system combines automated NMP technology with a patient support accessory device to provide support for a patient’s liver function.
“We are excited to partner with OrganOx to address a critical unmet need for patients with liver failure,” said Michael Curtis, Ph.D., CEO of eGenesis. “This collaboration is a crucial step in our mission to develop safe and effective human-compatible organs for patients suffering from organ failure.”
