Maze Therapeutics begins Phase 2 trial for kidney disease drug

SOUTH SAN FRANCISCO – Maze Therapeutics, Inc. (NASDAQ: MAZE), a clinical-stage biopharmaceutical company with a market capitalization of $569 million, has dosed the first patient in its Phase 2 HORIZON Study of MZE829, targeting APOL1 kidney disease (AKD). According to InvestingPro analysis, while the company is currently trading below its Fair Value, it maintains a strong financial health score of 3.3, rated as "GREAT" by the platform’s comprehensive evaluation system. The trial aims to address a significant medical need for over one million U.S. patients suffering from this chronic condition. While the company is not yet profitable, InvestingPro data shows it maintains excellent liquidity with a current ratio of 8.77, indicating strong financial flexibility to support its clinical development programs.

MZE829, an oral APOL1 inhibitor, is being investigated as a novel treatment for AKD, which is a subset of chronic kidney disease. The HORIZON Study is an open-label trial designed to include a broad spectrum of AKD patients, including those with severe disease and nephrotic range proteinuria, such as focal segmental glomerulosclerosis (FSGS), and diabetic kidney disease. This marks the first instance of a small molecule APOL1 inhibitor being studied in diabetic AKD patients.

The primary endpoint of the HORIZON Study is the reduction of proteinuria, measured by a 30% or greater reduction from baseline in urinary albumin-to-creatinine ratio (uACR) at week 12. A decrease in uACR is considered to offer a clinically meaningful benefit, as it is a sensitive measure of proteinuria across stages of kidney disease, especially in hypertension and diabetes, and can indicate cardiovascular disease risk.

Maze anticipates an interim data readout in the first quarter of 2026, which could provide potential proof of concept for MZE829. With a moderate debt level and robust cash position, the company appears well-positioned to advance its clinical programs. Get deeper insights into Maze’s financial health and 7 additional key ProTips with an InvestingPro subscription. The company’s R&D President and Chief Medical (TASE:PMCN) Officer, Harold Bernstein, M.D., Ph.D., expressed optimism about the HORIZON Study’s potential to refine patient selection for future pivotal trials and offer a disease-modifying therapy for AKD patients.

The trial’s initiation follows Maze’s multicenter, clinical observational study begun in August 2024 to identify black and African American individuals with APOL1 G1 and G2 mutations and to explore kidney disease biomarkers.

Maze Therapeutics is advancing a pipeline of precision medicines for renal, cardiovascular, and metabolic diseases using its Compass platform, which links genetic variants with biological pathways in specific patient groups. The company’s pipeline features two wholly owned lead programs, including MZE829.

This news is based on a press release statement from Maze Therapeutics.

In other recent news, Maze Therapeutics, a clinical-stage biopharmaceutical company, has made its debut on the Nasdaq Global Market with shares starting to trade at $16.12. The company priced 8,750,000 shares of its common stock in its initial public offering (IPO) at a public offering price of $16.00 per share. The IPO is being managed by a team of joint bookrunners, including J.P. Morgan, TD Cowen, Leerink Partners, and Guggenheim Securities. In addition to the initial offering, Maze Therapeutics has extended a 30-day option to underwriters to buy up to an additional 1,312,500 shares of common stock at the initial offering price, minus underwriting discounts and commissions. The company’s primary focus areas are renal, cardiovascular, and related metabolic diseases, including obesity. Maze Therapeutics’ pipeline is spearheaded by two wholly owned lead programs, MZE829 and MZE782, representing a new precision medicine-based approach for chronic kidney disease. These recent developments highlight the company’s ongoing efforts to advance in the biopharmaceutical sector.

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