MAZE MAZE THERAPEUTICS INC

Maze Therapeutics to Present Additional Data Highlighting the Advancement of MZE829 and MZE782 Programs at ASN Kidney Week

Maze Therapeutics to Present Additional Data Highlighting the Advancement of MZE829 and MZE782 Programs at ASN Kidney Week

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today announced seven presentations at the American Society of Nephrology’s (ASN) Kidney Week, being held November 6-9 in Houston, Texas.

During the meetings, Maze Therapeutics will present additional pharmacokinetic data from its Phase 1 clinical trial of MZE782, as well as preclinical research supporting inhibition of SLC6A19 to slow disease progression in chronic kidney disease (CKD). MZE782 is a novel, oral SLC6A19 inhibitor with the potential to be a best-in-class therapy for patients with phenylketonuria (PKU), an inherited metabolic disorder, and a first-in-class therapy for CKD. Additionally, Maze will present research supporting the scientific foundation and therapeutic rationale for MZE829, an oral, small molecule inhibitor currently in Phase 2 development for APOL1-mediated kidney disease (AMKD). AMKD is a subset of CKD estimated to affect over one million people in the United States alone.

“We’re pleased to share updated data at ASN from our two lead programs, MZE782 and MZE829, that underscore the steady progress across our pipeline,” said Harold Bernstein, M.D., Ph.D., president of R&D and chief medical officer at Maze. “The additional genetic analysis of SLC6A19 reinforces its potential as a promising target for the treatment of patients with CKD, and the Phase 1 data for MZE782 provide further context supporting its potential as a novel treatment for both PKU and CKD. The MZE829 findings continue to validate the strong scientific foundation of our differentiated molecule and approach to treating a broad AMKD patient population, including those with diabetes. We look forward to engaging with the scientific community at ASN as we advance our mission of translating genetic insights into meaningful therapies for patients.”

Details of the presentations are as follows:

Title: [TH-PO0740] Multicenter, Observational, Cross-Sectional Study to Estimate the Frequencies of APOL1 Genetic Variants in Adult Black and African American Patients with Proteinuric Kidney Disease

Date and Time: 11/6/2025; 10:00am-12:00pm CT

Title: [TH-PO0603] Small Molecule Inhibitors of APOL1 Reverse Dysfunctional Signaling Mediated by APOL1 Risk Variants in Immortalized Human Podocytes

Date and Time: 11/6/2025; 10:00am-12:00pm CT

Title: [TH-PO0648] APOL1 High Risk Variants Associated with CKD Progression in People with Diabetes

Date and Time: 11/6/2025; 10:00am-12:00pm CT

Title: [TH-OR033] Functional Mapping of APOL1 G1 Reveals Key Regions Modulating Cytotoxicity and Inhibitor Sensitivity

Date and Time: 11/6/2025; 5:20-5:30pm CT

Title: [TH-OR018] Experimentally Validated SLC6A19 Loss of Function Variants Improve Kidney Function and Reduce Progression to Kidney Failure

Date and Time: 11/6/2025; 5:50-6:00pm CT

Title: [FR-PO1207] Small Molecule Inhibition of SLC6A19 for the Treatment of CKD

Date and Time: 11/7/2025; 10:00am-12:00pm CT

Title: [SA-PO0235] Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Proof-of-Mechanism of MZE782, a Specific Inhibitor of SLC6A19 for the Treatment of CKD: Phase 1 Study in Healthy Adults

Date and Time: 11/8/2025; 10:00am-12:00pm CT

About MZE829

MZE829 is an oral, small molecule APOL1 inhibitor in development as a potential best-in-class treatment for APOL1-mediated kidney disease (AMKD), a subset of chronic kidney disease (CKD) estimated to affect more than one million people in the United States. The company is currently enrolling patients in the Phase 2 HORIZON trial, an open-label basket design trial that will enroll APOL1-mediated kidney disease (AMKD) 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 AMKD, including patients with more severe disease who have nephrotic level 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. Maze expects to have an initial topline readout from HORIZON in the first quarter of 2026.

About MZE782

MZE782 is an investigational, potent, oral inhibitor of SLC6A19 that Maze is advancing for the treatment of phenylketonuria (PKU) and chronic kidney disease (CKD). SLC6A19 is a sodium-dependent neutral amino acid transporter expressed in the small intestine and proximal tubule in the kidney that plays a key role in the absorption and reabsorption of neutral amino acids, including phenylalanine (Phe). By targeting this pathway, MZE782 offers a novel approach to lowering Phe levels in patients with PKU, independent of genotype or phenylalanine hydroxylase activity, and may help reduce metabolic stress and slow disease progression in CKD. In the Phase 1 clinical study in healthy volunteers, MZE782 demonstrated an excellent safety profile, sustained urinary neutral amino acid excretion as well as potential to improve kidney filtration. Maze plans to advance MZE782 into Phase 2 studies in both PKU and CKD in 2026.

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company that harnesses the power of human genetics to develop novel small molecule precision medicines for patients with kidney and metabolic diseases, including obesity. Guided by its CompassTM platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), and MZE782, a SLC6A19 inhibitor advancing to Phase 2 with the potential to treat both phenylketonuria (PKU) and chronic kidney disease (CKD). Maze is headquartered in South San Francisco. For more information, please visit , or follow the company on and .

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat CKD, PKU or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, and the ability to drive financial results and stockholder value. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

For further information, please contact:

IR/Corporate Contact:

Amy Bachrodt, Maze Therapeutics

Media Contact:

Amanda Lazaro, 1AB Media



EN
06/11/2025

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