German biotech HepaRegenix has successfully closed a €15 million Series C funding round to propel the clinical development of its lead candidate, HRX-215, a regenerative liver therapy. The funding will support Phase 1b and Phase 2a clinical trials, evaluating the drug's ability to induce liver regeneration in patients with severe liver diseases.
HRX-215: Targeting MKK4 for Liver Regeneration
HRX-215 is designed to inhibit Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4), a crucial regulator of liver regeneration. Research led by Prof. Lars Zender at the University Hospital Tübingen demonstrated that MKK4 suppression could stimulate hepatocyte regeneration, even in severely diseased livers. This mechanism of action offers a potential breakthrough in treating both acute and chronic liver conditions.
"MKK4 is a key regulator of liver regeneration, and MKK4 inhibition has been shown to induce liver regeneration after a partial hepatectomy," said Dr. Linda Greenbaum, HepaRegenix’s new CMO. "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."
Clinical Trial Plans and Leadership Transition
With Phase 1 trials already completed, the new funding will facilitate a Phase 1b clinical trial in the United States and an international multicenter Phase 2a clinical trial. These trials aim to assess the safety and efficacy of HRX-215 in inducing liver regeneration. HepaRegenix also announced the appointment of Elias Papatheodorou as CEO, succeeding his role as Chairman, and the addition of Dr. Linda Greenbaum, formerly of Novartis, as Chief Medical Officer.
Preclinical Evidence Supports Therapeutic Potential
Preclinical studies have demonstrated HRX-215's potential in various animal models. Notably, a murine model of nonalcoholic steatohepatitis (NASH)-associated hepatocellular carcinoma (HCC) showed a reduction in hepatic steatosis and liver damage, along with significant growth suppression of the carcinoma. Further studies indicated that inhibiting MKK4 enhances hepatocyte proliferation in both mice and pigs, increases hepatocyte robustness, reduces alcohol-induced steatosis and chronic NASH, and decreases liver lipids without affecting body or liver weight.
Investor Confidence and Future Implications
The funding round was led by Vesalius Biocapital IV, with participation from Novo Holdings, Boehringer Ingelheim Venture Fund, and High-Tech Gründerfonds. Fabienne Roussel from Vesalius will also join the Board of Directors.
"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," said Roussel. "HRX-215 has potential to help these patients and make a meaningful impact on their lives."
