HepaRegeniX Completes Phase Ib Study for Liver Drug
What happened
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.
Why it matters
- 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.
Key numbers
- German biotech firm HepaRegeniX has completed a Phase Ib clinical study of its drug candidate, HRX-215.
- - 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.
- Their work identified MKK4 as a master regulator of liver regeneration.
What happens next
- 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.
Quick answers
What happened in 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.
Why does HepaRegeniX Completes Phase Ib Study for Liver Drug matter?
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.
