HepaRegeniX Completes Phase Ib Study for Liver Drug
German biotech firm HepaRegeniX has completed a Phase Ib clinical study of its drug candidate, HRX-215. The study evaluated the drug's potential for liver regeneration following minor liver resection surgery. The trial's completion marks a step forward in the field of regenerative medicine for organ health.
- The drug candidate, HRX-215, is a first-in-class oral small molecule that works by inhibiting Mitogen-Activated Protein Kinase Kinase 4 (MKK4). MKK4 is a key negative regulator that suppresses the liver's natural ability to regenerate; inhibiting it unlocks the regenerative capacity of liver cells, even in severely diseased livers. - The scientific foundation for this therapeutic approach was established by Professor Lars Zender and his research group at the University Hospital Tuebingen in Germany. Their work identified MKK4 as a master regulator of liver regeneration. - The first part of the Phase Ib trial, which was just completed, enrolled five patients at the Mayo Clinic in the U.S. These patients received a 250 mg oral dose of HRX-215 twice daily for 28 days following minor liver resection for colorectal liver metastases. - Preclinical studies demonstrated significant efficacy, where the MKK4 inhibitor allowed pigs to survive what would have been a lethal 85% liver resection. The compound also showed anti-fibrotic and anti-steatotic (fat-reducing) effects in mouse models of liver disease. - HepaRegeniX is now advancing to the next part of the study, which will enroll ten patients undergoing major liver resections (50-72% of the liver removed) across sites in the U.S., Europe, and Israel. Following this, the company plans to initiate a larger, international, placebo-controlled Phase IIa trial. - The company is well-funded for these next steps, having announced a €15 million Series C round and a completed €21.5 million financing round from a syndicate of investors that includes Vesalius Biocapital, Novo Holdings, Boehringer Ingelheim Venture Fund, and Wellington Partners. - The potential application of HRX-215 extends beyond post-surgical regeneration, with the company exploring its use to treat severe alcohol-associated hepatitis and to facilitate the transplantation of smaller living donor liver grafts. - Beyond its primary focus on liver disease, HepaRegeniX is also leveraging its expertise in kinase inhibitors to develop another drug, HRX-233, which is aimed at targeting treatment resistance in KRAS-driven tumors.
