HepaRegeniX GmbH has announced the dosing of the first patient in its Phase Ib clinical trial of HRX-215, a novel small-molecule inhibitor designed to promote liver regeneration. This marks a significant step forward for the German biotech company who released this press release on June 10, 2025, in its mission to develop new therapies for patients with acute and chronic liver diseases, especially those at risk of liver failure.
HRX-215 is part of a new class of drugs known as MST1/2 kinase inhibitors. These compounds work by targeting the MST1/2 kinases, enzymes that act as gatekeepers in the liver’s regenerative processes. In preclinical studies, inhibiting MST1/2 has shown to activate the body’s natural ability to repair and regrow liver tissue—an approach that holds promise for patients whose livers are unable to recover due to disease or injury.
The Phase Ib study is a multi-center, double-blind, placebo-controlled trial. Its main goal is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRX-215 in patients with acute-on-chronic liver failure (ACLF) and acute decompensation of cirrhosis. These are conditions associated with high mortality and few effective treatments. By assessing different dose levels, the study aims to identify a safe and potentially effective dose that can move forward into larger clinical trials.
Dr. Michael Lutz, CEO of HepaRegeniX, expressed optimism about the trial’s potential impact. He emphasized the urgent need for innovative therapies in liver medicine and noted that HRX-215 could become the first drug specifically designed to enhance liver regeneration in critically ill patients. The company believes that successful results from this trial could open the door to new approaches in treating liver failure and reducing the need for transplants.
The initiation of this clinical trial builds on strong preclinical data and a successful first-in-human (Phase Ia) trial, which demonstrated the compound’s safety in healthy volunteers. With the first patient now dosed, HepaRegeniX is moving closer to its goal of advancing HRX-215 as a transformative therapy for liver disease patients. The company plans to share further updates as the study progresses and enrollment continues.
