HepaRegeniX, a clinical-stage company advancing novel therapies to treat acute and chronic liver diseases, announced that the company’s co-founder, Prof. Dr. med. Lars Zender, gave the Karl Wilhelm von Kupffer Basic Science plenary talk at the 2025 European Association for the Study of the Liver (EASL) Congress.
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EASL Congress, 7-10th May, Amsterdam, The Netherlands.
Titled “From bench to bedside: a success story in liver regeneration”, the plenary presented the discovery of the small molecule, HRX-215, its role in inhibiting the activity of the kinase MKK4, a key regulator of liver regeneration, and the evaluation of HRX-215 to date including Phase I clinical trial results validating its favourable safety and pharmacokinetic profile.
As an acknowledged leader in basic and translational liver research, Prof. Zender discussed the discovery of Mitogen Activated Protein (MAP) Kinase Kinase 4 (MKK4) as a master regulator of liver regeneration. This insight led to the characterisation of HepaRegeniX’s lead candidate, HRX-215, an orally-available small molecule inhibitor of MKK4 that has been shown to stabilise hepatocytes and increase regeneration, even in diseased livers. In the most impactful demonstration of its liver regeneration capabilities, HRX-215 strongly improved prognosis and survival outcomes in an experimental model of extended, lethal 85% liver resection in pigs. The experiment highlighted the significant potential for therapeutic benefit beyond current treatment options for severe liver diseases and was originally published in the journal Cell. Currently, HRX-215 is in a Phase Ib trial for the prevention of post-hepatectomy liver failure.
“The development of this first molecularly targeted therapy for increasing liver regeneration stands as a prime example of how functional genetic screens can pinpoint novel therapeutic targets and result in innovative therapeutic approaches,” said HepaRegeniX co-founder, Lars Zender. “From the discovery of the molecular target to the generation of highly validating preclinical and clinical data, HRX-215 shows the importance of translational science.”
“As the data presented today show that HRX-215 can unlock regeneration in an unprecedented manner, it could increase the safety of extended oncological liver resection surgeries and might also enable living donor liver transplantation with small grafts, providing a possible therapeutic solution for an area of unmet medical need,” said Elias Papatheodorou, chief executive officer at HepaRegeniX. “We continue to benefit from our collaboration with Lars and his lab. After the recent second close of our Series C funding, we are well-positioned to advance this program through Phase IIa.”
The EASL Congress is a hepatology forum in Europe, bringing together thousands of innovators and leaders in liver research. The State-of-the-Art lecture series, including the Karl Wilhelm von Kupffer Basic Science session, showcases key opinion leaders, allowing them to share the latest groundbreaking scientific advances.