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Prof. Lars Zender's featured talk described HepaRegeniX's lead candidate and its potential in increasing liver regeneration, from initial target discovery and drug development towards Phase Ia clinical trial results
Tuebingen, Germany, May 8, 2025 - HepaRegeniX GmbH ("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 State-of-the-Art plenary talk at the 2025 European Association for the Study of the Liver (EASL) Congress today. 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 favorable 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 characterization of HepaRegeniX's lead candidate, HRX-215, an orally-available small molecule inhibitor of MKK4 that has been shown to stabilize 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,” commented 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.”
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The EASL Congress is the leading 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.
About HepaRegeniX GmbH
HepaRegeniX is advancing therapies to treat acute and chronic liver diseases based on the groundbreaking discoveries of a novel cellular target and small molecules that enable the liver to regenerate rapidly. We do so by harnessing the liver's inherent regenerative power not only in healthy but also in diseased livers. The company's lead candidate, HRX-215, an orally available small molecule currently in a Phase Ib/IIa trial, selectively inhibits Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4), a master regulator of liver regeneration. Building on demonstrated safety in clinical trials, HepaRegeniX is progressing HRX-215 to prevent post-hepatectomy liver failure, facilitate transplantation of smaller living donor liver grafts, and treat severe alcohol-associated hepatitis. Beyond liver diseases, the company is also developing HRX-233 to target kinase inhibitor treatment resistance in KRAS-driven tumors.
HepaRegeniX is backed by experienced life science investors, including Vesalius Biocapital IV, Novo Holdings A/S, Boehringer Ingelheim Venture Fund (BIVF), Coparion, High-Tech Gründerfonds, Ascenion GmbH and Wellington Partners.
Visit our website at www.heparegenix.com to learn more about the company.
For further information, please contact:
HepaRegeniX GmbH
Elias Papatheodorou
Chief Executive Officer
Media Inquiries
Trophic Communications
Charlotte Spitz or Gretchen Schweitzer
Tel: +49 171 351 2733
Email: [email protected]
