SOUTH SAN FRANCISCO, CA, USA I February 07, 2025 I Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular, and metabolic diseases, today announced the first patient has been dosed in the company’s Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients with APOL1 kidney disease (AKD). MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for people living with AKD, a subset of chronic kidney disease estimated to affect over one million patients in the United States alone.
“We are excited to announce the initiation of our HORIZON Study for MZE829, a Phase 2 clinical trial with a novel, potential new medicine that could disrupt current treatment for AKD,” said Harold Bernstein, M.D., Ph.D., president, R&D, and chief medical officer of Maze. “We have designed HORIZON to include a broad spectrum of patients, reflecting the diverse characteristics of AKD, beyond the narrow criteria of existing studies. By evaluating MZE829 across a wider population and organized by cohorts, we aim to demonstrate proof of concept and refine patient selection for future pivotal trials. With its potential to be a truly disease-modifying therapy, MZE829 represents hope for the many patients living with AKD, addressing a critical unmet need in kidney disease treatment.”
The HORIZON Study is a Phase 2, open-label basket design trial that will enroll AKD patients carrying the two high-risk APOL1 alleles (G1, G2), stratified by clinical phenotype and level of proteinuria, as well as patients who have type 2 diabetes. The trial will enroll patients with a wide array of characteristics of AKD, including patients with more severe disease who have nephrotic range proteinuria, such as those with focal segmental glomerulosclerosis (FSGS), patients with lower levels of proteinuria and hypertensive nephropathy, and patients with proteinuria and diabetic kidney disease. The HORIZON study is the first clinical trial with a small molecule APOL1 inhibitor to study diabetic AKD patients. Maze initiated a multicenter, clinical observational study in August 2024 to identify black and African American individuals who carry the APOL1 G1 and G2 mutations, and to explore kidney disease biomarkers in patients with proteinuric kidney disease.
The primary endpoint of the HORIZON Study is reduction of proteinuria, or elevated protein in the urine, as measured by the percentage of subjects with a 30% or greater reduction from baseline in urinary albumin-to-creatinine ratio (uACR) at week 12, a reduction threshold that is expected to offer clinically meaningful benefit, according to external, published literature.1 uACR is a sensitive measure of proteinuria across stages of glomerular kidney disease, particularly in hypertension and diabetes, and has been used to assess risk of cardiovascular disease. Maze expects to have a potential proof of concept interim data readout in the first quarter of 2026.
About Maze Therapeutics
Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for patients. For more information, please visit mazetx.com, or follow us on LinkedIn and X (formerly Twitter).
1 https://pubmed.ncbi.nlm.nih.gov/30635226/
SOURCE: Maze Therapeutics
Post Views: 85
SOUTH SAN FRANCISCO, CA, USA I February 07, 2025 I Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular, and metabolic diseases, today announced the first patient has been dosed in the company’s Phase 2 clinical trial, the HORIZON Study, of MZE829 in patients with APOL1 kidney disease (AKD). MZE829 is an oral, small molecule APOL1 inhibitor that Maze is advancing as a potential treatment for people living with AKD, a subset of chronic kidney disease estimated to affect over one million patients in the United States alone.
“We are excited to announce the initiation of our HORIZON Study for MZE829, a Phase 2 clinical trial with a novel, potential new medicine that could disrupt current treatment for AKD,” said Harold Bernstein, M.D., Ph.D., president, R&D, and chief medical officer of Maze. “We have designed HORIZON to include a broad spectrum of patients, reflecting the diverse characteristics of AKD, beyond the narrow criteria of existing studies. By evaluating MZE829 across a wider population and organized by cohorts, we aim to demonstrate proof of concept and refine patient selection for future pivotal trials. With its potential to be a truly disease-modifying therapy, MZE829 represents hope for the many patients living with AKD, addressing a critical unmet need in kidney disease treatment.”
The HORIZON Study is a Phase 2, open-label basket design trial that will enroll AKD patients carrying the two high-risk APOL1 alleles (G1, G2), stratified by clinical phenotype and level of proteinuria, as well as patients who have type 2 diabetes. The trial will enroll patients with a wide array of characteristics of AKD, including patients with more severe disease who have nephrotic range proteinuria, such as those with focal segmental glomerulosclerosis (FSGS), patients with lower levels of proteinuria and hypertensive nephropathy, and patients with proteinuria and diabetic kidney disease. The HORIZON study is the first clinical trial with a small molecule APOL1 inhibitor to study diabetic AKD patients. Maze initiated a multicenter, clinical observational study in August 2024 to identify black and African American individuals who carry the APOL1 G1 and G2 mutations, and to explore kidney disease biomarkers in patients with proteinuric kidney disease.
The primary endpoint of the HORIZON Study is reduction of proteinuria, or elevated protein in the urine, as measured by the percentage of subjects with a 30% or greater reduction from baseline in urinary albumin-to-creatinine ratio (uACR) at week 12, a reduction threshold that is expected to offer clinically meaningful benefit, according to external, published literature.1 uACR is a sensitive measure of proteinuria across stages of glomerular kidney disease, particularly in hypertension and diabetes, and has been used to assess risk of cardiovascular disease. Maze expects to have a potential proof of concept interim data readout in the first quarter of 2026.
About Maze Therapeutics
Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular and related metabolic diseases, including obesity. The company is advancing a pipeline using its Compass platform, which provides insights into the genetic variants in disease and links them with the biological pathways that drive disease in specific patient groups. The company’s pipeline is led by two wholly owned lead programs, MZE829 and MZE782, each of which represents a novel precision medicine-based approach for patients. For more information, please visit mazetx.com, or follow us on LinkedIn and X (formerly Twitter).
1 https://pubmed.ncbi.nlm.nih.gov/30635226/
SOURCE: Maze Therapeutics
Post Views: 85
