Tuebingen, Germany, June 10, 2025 – HepaRegeniX, a clinical-stage company focused on developing innovative treatments for both acute and chronic liver conditions, announced today that the first patient has received a dose in its Phase Ib clinical trial for its primary drug candidate, HRX-215. The trial is designed to assess the safety and effectiveness of HRX-215, an orally administered small-molecule inhibitor of MKK4, in patients undergoing partial liver removal due to liver metastases originating from colorectal cancer. HRX-215 aims to treat advanced liver disease by enhancing the liver’s capacity to regenerate hepatocytes. Initial data from the trial is expected in the latter half of 2025.

According to Linda Greenbaum, Chief Medical Officer at HepaRegeniX, “Our goal is to address a significant unmet need among patients with advanced liver disease who are often deemed ineligible for surgery because of the limited regenerative ability of the remaining liver following partial removal.” She added, “HRX-215 has the potential to provide a novel therapeutic approach by stimulating hepatocyte regeneration, which could improve the safety and viability of liver resections in patients with insufficient predicted post-operative liver mass and/or impaired liver function linked to fatty liver (steatosis) or liver scarring (fibrosis).”

Elias Papatheodorou, Chief Executive Officer at HepaRegeniX, stated, “The dosing of the first patient in this trial represents a crucial milestone for HepaRegeniX as we advance HRX-215 further in clinical development.” He also noted, “Combined with our recently closed €21.5 million Series C financing, we are well-positioned to continue the clinical advancement of HRX-215 and, ultimately, improve outcomes for patients who have limited treatment options.”

The Phase Ib/IIa trial, a randomized, double-blind study, will be conducted in the United States to evaluate the safety and efficacy of HRX-215 in 85 patients who have liver metastases from colorectal cancer. Participants will be divided into three groups: (1) an active treatment group for patients needing minor liver resection ( 30%), (2) an active treatment group for patients needing major liver resection (50 – 72%), and (3) active treatment and a placebo comparator groups for patients needing major liver resection.

This study is based on results obtained in March 2024, which indicated HRX-215’s ability to significantly enhance liver regeneration and prevent post-hepatectomy liver failure (PHLF) in animal studies. The Phase I trial in healthy participants also demonstrated an acceptable safety profile and pharmacokinetics. The compound demonstrated good safety and tolerability, with no drug-related adverse events reported.

About HRX-215 and Liver Regeneration
Patients in the advanced stages of liver disease frequently have few treatment options other than surgery. The success of liver resection hinges on the capacity of the remaining liver, known as the future liver remnant (FLR), to maintain essential functions and regenerate. If the FLR has insufficient volume or function, the risk of post-operative liver failure rises considerably, making many patients ineligible for potentially curative surgery.

HRX-215 is an orally bioavailable small molecule that inhibits mitogen-activated protein kinase kinase 4 (MKK4), a crucial regulator of liver regeneration. Preclinical studies have demonstrated that HRX-215, through its selective inhibition of MKK4, can stabilize and protect hepatocytes, while also accelerating and improving regenerative processes, even in damaged or diseased livers. This therapeutic strategy offers the potential to broaden surgical eligibility to patients requiring extensive liver resection who might otherwise be considered inoperable, thus providing a new avenue for potentially life-saving treatment.

About HepaRegeniX GmbH
HepaRegeniX is dedicated to developing therapies for acute and chronic liver diseases, building on breakthrough discoveries related to a novel cellular target and small molecules that facilitate rapid liver regeneration. We achieve this by leveraging the liver’s inherent regenerative capacity, not only in healthy livers but also in those affected by disease. The company’s leading 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 key regulator of liver regeneration. Based on the safety demonstrated in clinical trials, HepaRegeniX is advancing 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 supported 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.

For more information about the company, please visit our website at .

For further information, please contact:
HepaRegeniX GmbH
Elias Papatheodorou
Chief Executive Officer

Media Inquiries
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Charlotte Spitz or Gretchen Schweitzer
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