Maze Therapeutics has announced the initiation of a Phase 1 clinical trial evaluating MZE782, a potential first-in-class oral small molecule therapy, for the treatment of chronic kidney disease (CKD). The trial, a randomized, double-blind, placebo-controlled study, is enrolling healthy volunteers to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of MZE782. This drug targets the solute transporter SLC6A19 and aims to address the needs of approximately five million CKD patients in the United States who do not respond adequately to currently available therapies.
Targeting SLC6A19 for Kidney Protection
MZE782 is designed to mimic the kidney-protective effects observed in individuals with protective variants of SLC6A19. Harold Bernstein, M.D., Ph.D., president, R&D, and chief medical officer of Maze, stated that SLC6A19 was identified using their Compass platform as a promising treatment target. The drug has the potential to be a first-in-class therapy for patients who do not respond to current treatments.
Trial Design and Anticipated Results
The Phase 1 trial will evaluate single and multiple ascending doses of MZE782. The primary endpoints include safety and tolerability, while secondary endpoints will focus on pharmacokinetic and pharmacodynamic parameters, measured by urinary excretion of neutral amino acids. Initial results, including potential proof-of-mechanism data utilizing biomarkers, are expected in the second half of 2025.
Potential as a Standalone or Combination Therapy
Maze Therapeutics believes that MZE782 could be used as a standalone therapy or in combination with the current standard of care for CKD. This includes its potential as a complementary treatment to existing regimens or as an alternative for patients who do not respond to current treatments. Given that approximately 37 million people in the United States have CKD, with a significant portion not responding well to existing therapies, MZE782 represents a potentially significant advancement in the treatment landscape.
