HepaRegeniX initiates first-in-man Phase 1 trial for its lead MKK4 inhibitor HRX-0215
HRX-0215 is the first compound from the company ́s small molecule-based drug discovery platform ready for clinical testing
Tubingen (Germany), August 10, 2021 – HepaRegeniX GmbH, a clinical stage company developing novel therapies for the treatment of acute and chronic liver diseases, announced today the first dosing of its lead drug candidate HRX-0215 in a Phase 1 clinical trial. HRX-0215 is a small molecule inhibitor of Mitogen-Activated Protein (MAP) Kinase Kinase 4 (MKK4), a key regulator of liver regeneration. Suppression of MKK4 unlocks the regenerative capacity of hepatocytes even in severely diseased livers.
The single-center, double-blind, randomized, placebo-controlled trial plans to enroll 48 healthy male volunteers. The trial will assess the safety, tolerability, and pharmacokinetics of HRX-0215 and is designed as a single and multiple dose escalation study (SAD/MAD). HepaRegeniX expects the first results later this year. Previous extensive preclinical studies demonstrated compelling efficacy of HRX-0215 in both acute and chronic liver disease models.