HepaRegeniX GmbH announced positive topline results from its Phase 1 clinical trial of HRX-0215, a first-in-class inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4), showcasing a promising safety and tolerability profile in healthy volunteers. The successful completion of this phase marks a significant step forward in developing novel regenerative therapies for acute and chronic liver diseases.
The Phase 1 trial (EUDRA-CT No. 2021-000193-28) was a single-center, double-blind, randomized, placebo-controlled study involving 48 healthy male volunteers. It was designed as a single and multiple dose escalation study (SAD/MAD) to assess the safety, tolerability, and pharmacokinetics of HRX-0215.
Key Findings from the Phase 1 Trial
The trial results indicated that HRX-0215 was well-tolerated at all doses, with no drug-related adverse events reported. Furthermore, no clinically relevant changes in clinical or laboratory parameters were observed. Vital signs remained stable, and ECG parameters were unremarkable, confirming the safety of HRX-0215 in this population.
Pharmacokinetic analysis revealed a dose-proportional increase in exposure with very low interindividual variability within a given dosing strength. This favorable pharmacokinetic profile supports further clinical development and dose optimization in subsequent trials.
MKK4 Inhibition and Liver Regeneration
HRX-0215 functions by inhibiting MKK4, a key regulator of liver regeneration. Suppression of MKK4 unlocks the regenerative capacity of hepatocytes, even in severely diseased livers. This mechanism of action has shown compelling efficacy in preclinical studies, demonstrating potential in both acute and chronic degenerative liver disease models.
Future Directions
HepaRegeniX plans to further investigate HRX-0215 in Phase 2 trials to evaluate its efficacy in patients with liver diseases. "We are very proud to have successfully concluded the clinical Phase 1 with HRX-0215...confirming safety and tolerability is a very important clinical milestone," commented Dr. Wolfgang Albrecht, Managing Director and COO of HepaRegeniX. "We will continue our work on improving the currently poor prognosis and very few therapeutic options of the ever-increasing number of people living with severe liver diseases."
