Maze Therapeutics Begins Phase 1 Trial of MZE782 for Chronic Kidney Disease

Maze Therapeutics, a clinical-stage biopharmaceutical company based in South San Francisco, has commenced its Phase 1 clinical trial for MZE782, an innovative oral small molecule therapy. This potential first-in-class treatment targets the solute transporter SLC6A19 and is aimed at improving outcomes for patients with chronic kidney disease (CKD). The trial's initiation marks a significant milestone for Maze Therapeutics as it seeks to address a substantial unmet need in CKD treatment.

Chronic kidney disease is a serious and progressive condition affecting millions in the United States. Current therapies typically focus on slowing the progression of the disease rather than addressing its genetic underpinnings. Maze Therapeutics, utilizing its Compass platform, has identified SLC6A19 as a promising target for CKD treatment. MZE782 has been designed to mimic the kidney protective effects of certain SLC6A19 genetic variants, offering hope for approximately five million CKD patients in the U.S. who do not respond adequately to existing therapies.

Dr. Harold Bernstein, President of R&D and Chief Medical Officer at Maze Therapeutics, emphasized the significance of this development. He noted that this is the company's third clinical program and highlighted the importance of the first-in-human clinical trial in understanding MZE782's therapeutic potential. The trial will not only assess the safety and tolerability of the drug but also provide crucial pharmacokinetic and pharmacodynamic data. These insights, gained through the use of a non-invasive biomarker, are expected to optimize the design of future clinical trials in CKD patients. Maze anticipates sharing initial results, including proof of mechanism data, in the second half of 2025.

The Phase 1 trial is a randomized, double-blind, placebo-controlled study involving single and multiple ascending doses in healthy volunteers. The primary goal is to evaluate the safety and tolerability of MZE782. Additionally, the trial will measure pharmacokinetics and pharmacodynamics, specifically through the urinary excretion of known SLC6A19 cargo, such as neutral amino acids.

MZE782 holds promise not only as a standalone therapy but also as a complementary treatment to the current standard of care. It could significantly benefit patients when used in combination with existing approved regimens or as an alternative for those who do not adequately respond to current treatments.

Maze Therapeutics is committed to leveraging human genetics for the development of novel precision medicines targeting common diseases, with a particular focus on renal, cardiovascular, and related metabolic conditions, including obesity. The company's approach is grounded in its Compass platform, which identifies genetic variants associated with diseases and links them to the biological pathways that drive disease in specific patient groups. Maze's pipeline includes two lead programs, MZE829 and MZE782, both of which represent innovative precision medicine approaches for treating chronic kidney disease.

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