Maze Therapeutics has dosed the first subject in the Phase II HORIZON study to evaluate its oral apolipoprotein L1 (APOL1) inhibitor, MZE829, in treating subjects with APOL1 kidney disease (AKD).
Subjects with two high-risk APOL1 alleles (G1, G2), will be enrolled in the trial where they will be stratified based on proteinuria levels and clinical phenotype.
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The trial will also include individuals with severe nephrotic range proteinuria and conditions like focal segmental glomerulosclerosis (FSGS), as well as those with lower proteinuria levels, hypertensive nephropathy, and diabetic kidney disease.
It is an open-label basket design trial and claims to be the first to include diabetic AKD subjects in its small molecule APOL1 inhibitor research.
Reduction of proteinuria, measured by a 30% or greater decrease from baseline in the urinary albumin-to-creatinine ratio (uACR) at week 12, is the study’s primary endpoint.
uACR is a sensitive proteinuria measure, especially in hypertension and diabetes, and is linked to cardiovascular disease risk assessment.
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By GlobalDataThe proof-of-concept interim data is expected in the first quarter of 2026.
Maze Therapeutics R&D president and chief medical officer Harold Bernstein said: “We are excited to announce the initiation of our HORIZON Study for MZE829, a Phase II clinical trial with a novel, potential new medicine that could disrupt current treatment for AKD.
“By evaluating MZE829 across a wider population and organised by cohorts, we aim to demonstrate proof of concept and refine patient selection for future pivotal trials.”
AKD, a subset of chronic kidney disease affects over one million individuals in the US.
Maze is also conducting a clinical observational trial to detect black and African American subjects carrying the high-risk APOL1 alleles and to investigate kidney disease biomarkers.
This study started in August 2024 to understand proteinuric kidney disease in these populations.
In February 2023, the company reported positive outcomes from its Phase I trial of MZE001 in healthy volunteers. This trial is part of the company’s efforts as an oral treatment for Pompe disease.
