HepaRegeniX GmbH has announced the closing of a €15 million Series C funding round to advance the clinical development of HRX-215, a novel regenerative therapy for acute and chronic liver diseases. The financing, led by Vesalius Biocapital IV with participation from existing investors, will support a Phase Ib clinical trial in the US and an international multicenter Phase IIa clinical trial focused on liver regeneration.
HRX-215: A Novel Approach to Liver Regeneration
HRX-215 is a small molecule inhibitor targeting Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4). Inhibition of MKK4 unlocks the regenerative capacity of hepatocytes, potentially boosting liver regeneration in patients. This mechanism is particularly relevant for patients with liver metastases or primary liver tumors, where resection is often the only curative option. Liver regeneration is also crucial in liver transplant scenarios, especially in enabling left liver lobe living donor transplants, which could reduce waiting lists.
Clinical Development and Preclinical Data
Promising preclinical data have demonstrated HRX-215’s capacity for liver regeneration. HepaRegeniX has already completed a Phase I trial, with results published in Cell. The new funding will facilitate further clinical trials to assess HRX-215's efficacy in promoting liver recovery and preventing liver failure.
Leadership and Expertise
Dr. Linda Greenbaum, formerly Executive Director, Translational Medicine at Novartis and Director of Clinical Development at Janssen R&D, has joined HepaRegeniX as Chief Medical Officer (CMO). Dr. Greenbaum brings extensive experience in clinical development and translational medicine, including research on liver regeneration and fibrosis at Thomas Jefferson University and University of Pennsylvania.
"MKK4 is a key regulator of liver regeneration, and MKK4 inhibition has been shown to induce liver regeneration after a partial hepatectomy," said Dr. Greenbaum. "With this mode of action, HRX-215 has an immense potential to improve outcomes for patients who are currently not able to undergo potentially curative surgical resections due to liver tumors, and other patient groups affected by liver failure."
Investor Confidence
Fabienne Roussel, Partner at Vesalius Biocapital IV, commented, "There is an immense need for a treatment that can induce liver regeneration in patients suffering from liver damage, liver tumors, as well as in transplant settings. HRX-215 has potential to help these patients and make a meaningful impact on their lives."
