SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Maze Therapeutics, a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with common diseases, today announced positive results from the Phase 1 clinical trial of MZE829 in healthy volunteers.

加利福尼亚州南旧金山（商业新闻短讯）--Maze Therapeutics是一家临床阶段的生物制药公司，利用人类遗传学的力量为患有常见疾病的患者开发新型小分子精密药物，今天宣布了MZE829在健康志愿者中的一期临床试验的积极结果。

MZE829 is an oral, small molecule inhibitor of APOL1 that Maze is advancing as a potential treatment for people living with APOL1 kidney disease (AKD), a subset of chronic kidney disease estimated to affect over one million patients in the United States alone. APOL1 is a protein encoded by the APOL1 gene in humans.

MZE829是一种口服的APOL1小分子抑制剂，Maze正在成为APOL1肾病（AKD）患者的潜在治疗方法，AKD是慢性肾病的一个子集，估计仅在美国就有100多万患者受到影响。APOL1是人类中由APOL1基因编码的蛋白质。

Genetic variants of the gene (G1 and G2) are associated with increased risk for a spectrum of progressive kidney diseases in people of West African ancestry. MZE829 was identified through insights generated from Maze’s proprietary, purpose-built platform, Maze Compass™..

该基因的遗传变异（G1和G2）与西非血统人群中一系列进行性肾脏疾病的风险增加有关。MZE829是通过Maze专有的专用平台Maze Compass™产生的见解确定的。。

The first-in-human Phase 1 randomized, placebo-controlled, single and multiple ascending dose trial was designed to evaluate the safety, pharmacokinetics (PK), food effect, and potential drug interactions of orally administered MZE829 in healthy volunteers and enrolled 111 participants. Results demonstrated that MZE829 was well tolerated at single doses up to 480 mg and multiple doses up to 350 mg, with all treatment-related adverse events reported as mild and no severe or serious adverse events reported.

第一项人类第一阶段随机，安慰剂对照，单次和多次递增剂量试验旨在评估健康志愿者口服MZE829的安全性，药代动力学（PK），食物效应和潜在的药物相互作用，并招募了111名参与者。结果表明，MZE829在单次剂量高达480 mg和多次剂量高达350 mg时耐受性良好，所有治疗相关不良事件均报告为轻度，未报告严重或严重不良事件。

Dose-proportional PK was observed with low variability across doses. The observed half-life of approximately 15 hours supported that MZE829 can be dosed once daily. Evaluation of potential drug interactions demonstrated that MZE829 has the potential to be administered together with standard of care medicines used in patients with AKD, including cyclosporine and tacrolimus..

观察到剂量成比例的PK，剂量间的变异性很低。观察到的大约15小时的半衰期支持MZE829可以每天给药一次。对潜在药物相互作用的评估表明，MZE829有可能与AKD患者使用的标准护理药物（包括环孢素和他克莫司）一起使用。。

“We are very pleased with the positive outcome of our Phase 1 trial of MZE829, demonstrating its tolerability and establishing the dosing regimen that we plan to take into our Phase 2 trial in patients with AKD,” said Harold Bernstein, M.D., Ph.D., president, R&D, and chief medical officer of Maze. “Based on its mechanism targeting APOL1, as well as genetics data derived through our Compass platform, we believe that MZE829 has the potential to address a large population of patients with AKD.

梅兹医学博士、研发总裁兼首席医疗官哈罗德·伯恩斯坦（HaroldBernstein）表示：“我们对MZE829第一阶段试验的积极结果感到非常满意，证明了其耐受性，并建立了我们计划在AKD患者中进行的第二阶段试验的给药方案。”。“基于其针对APOL1的机制，以及通过我们的Compass平台获得的遗传学数据，我们认为MZE829有可能解决大量AKD患者的问题。

As such, we intend to enroll patients with a wide array of characteristics into our Phase 2 trial to reflect the full spectrum of AKD patients and determine which patients may benefit from treatment with MZE829.”.

因此，我们打算将具有多种特征的患者纳入我们的2期临床试验，以反映AKD患者的全部情况，并确定哪些患者可能从MZE829治疗中受益。”。

The company anticipates that the Phase 2 clinical trial will employ an open-label basket design to include a range of clinical phenotypes and moderate to severe forms of disease as determined by level of proteinuria. The Phase 2 trial will include AKD patients carrying two copies of the high-risk APOL1 alleles (G1 and G2) and evaluate efficacy using uACR reduction across a broad AKD population.

该公司预计，第二阶段临床试验将采用开放标签篮子设计，包括一系列临床表型和由蛋白尿水平决定的中重度疾病。第二阶段试验将包括携带两个拷贝的高危APOL1等位基因（G1和G2）的AKD患者，并在广泛的AKD人群中使用uACR降低来评估疗效。

The company expects to initiate the Phase 2 trial in the first quarter of 2025..

该公司预计在2025年第一季度启动第二阶段试验。。

About Maze Therapeutics

关于迷宫疗法

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 common diseases, with a focus on renal, cardiovascular and related metabolic, 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.

Maze Therapeutics是一家临床阶段的生物制药公司，利用人类遗传学的力量为患有常见疾病的患者开发新型小分子精密药物，重点关注肾脏，心血管和相关代谢，包括肥胖。该公司正在利用其Compass平台推进一条管道，该平台提供了对疾病遗传变异的见解，并将其与特定患者群体中驱动疾病的生物途径联系起来。

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 chronic kidney disease. For more information, please visit mazetx.com, or follow us on LinkedIn and X (formerly Twitter)..

该公司的管道由两个全资领先项目MZE829和MZE782领导，每个项目都代表了一种基于精准医学的慢性肾脏疾病新方法。有关更多信息，请访问mazetx.com，或在LinkedIn和X（以前的Twitter）上关注我们。。