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). Preclinical data suggests that inhibiting MKK4 can unlock the regenerative capacity of hepatocytes, potentially boosting liver regeneration in patients. This approach is particularly relevant for individuals with liver metastases or primary liver tumors, where resection is often the only curative option. Furthermore, enhanced liver regeneration could improve outcomes in liver transplant scenarios, especially in living donor transplants, potentially reducing waiting lists.
Clinical Development and Leadership Expansion
HepaRegeniX has already completed a Phase I trial with HRX-215, with results published in Cell. The new funding will enable the company to progress to Phase Ib and IIa trials. As part of this advancement, Dr. Linda Greenbaum has been appointed as Chief Medical Officer (CMO). Dr. Greenbaum brings extensive experience from Novartis and Janssen R&D, as well as prior research experience in liver regeneration and fibrosis at Thomas Jefferson University and University of Pennsylvania.
Expert Commentary
Elias Papatheodorou, transitioning from Chair of the Board to CEO, stated, “We are thrilled to secure this significant financing, which underscores the confidence our investors have in our science and our capabilities to bring effective treatments to patients suffering from liver diseases.”
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.”
Dr. Greenbaum added, “MKK4 is a key regulator of liver regeneration, and MKK4 inhibition has been shown to induce liver regeneration after a partial hepatectomy... I look forward to working with the talented team at HepaRegeniX to advance the clinical development of HRX-215 through Phase II trials and beyond, with the ultimate goal of improving outcomes for patients with liver diseases worldwide.”
