Eccogene, a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for chronic cardiometabolic and inflammatory conditions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MOSAIC, a Phase 2a trial evaluating ECC4703, ECC0509 and their combination in adults with presumed metabolic dysfunction-associated steatohepatitis (MASH)..

Eccogene是一家临床阶段的生物制药公司，致力于开发用于慢性心脏代谢和炎症疾病的下一代口服小分子疗法，该公司今天宣布，美国食品和药物管理局（FDA）已批准其新药研究（IND）申请，针对MOSAIC的二期临床试验，评估ECC4703、ECC0509及其组合在疑似代谢功能障碍相关脂肪性肝炎（MASH）成人患者中的效果。

“We are pleased to receive the FDA clearance to initiate our Phase 2a MOSAIC trial with ECC4703 and ECC0509 for MASH, which impacts millions of patients worldwide,” said Jingye Zhou, Chief Executive Officer of Eccogene. “As a liver targeting THR-β full agonist, ECC4703 is designed to deliver improved efficacy and tolerability compared to existing therapies.

“我们很高兴收到FDA的批准，可以启动ECC4703和ECC0509用于治疗MASH的二期a阶段MOSAIC试验，该疾病影响着全球数百万患者，”Eccogene首席执行官周靖烨表示。“作为一种靶向肝脏的THR-β完全激动剂，ECC4703旨在提供比现有疗法更高的疗效和耐受性。”

ECC0509 is our novel SSAO inhibitor engineered to address inflammatory and fibrotic pathways associated with MASH. The MOSAIC trial is designed to investigate these two individual therapies as well as their combined potential, aiming to tackle the complex challenge of MASH.”.

ECC0509是我们新型的SSAO抑制剂，旨在解决与MASH相关的炎症和纤维化通路。MOSAIC试验旨在研究这两种单独的疗法及其组合潜力，以应对MASH的复杂挑战。"

The MOSAIC trial is a U.S.-based, multicenter, randomized, double-blind, placebo-controlled Phase 2a trial that will evaluate the efficacy and safety of ECC4703, ECC0509, and the combination of the two in adults with presumed MASH. The 12-week study is expected to enroll approximately 160 participants.

MOSAIC 试验是一项基于美国的多中心、随机、双盲、安慰剂对照的 2a 期试验，将评估 ECC4703、ECC0509 及其联合疗法在疑似 MASH 成人患者中的疗效和安全性。这项为期 12 周的研究预计招募约 160 名参与者。

The primary endpoint is change in liver fat content..

主要终点是肝脏脂肪含量的变化。

About ECC4703

关于ECC4703

ECC4703 is an oral, once-daily, selective, liver targeting full agonist of the thyroid hormone receptor beta (THR-β) in development for the treatment of metabolic dysfunction–associated steatohepatitis (MASH) and other cardiometabolic diseases. Unlike partial agonists, ECC4703 is designed to deliver greater efficacy, with the potential to achieve deeper reductions in atherogenic lipids, greater hepatic fat clearance, and favorable effects on inflammation and fibrosis improvement.

ECC4703 是一种口服、每日一次、选择性、靶向肝脏的甲状腺激素受体β（THR-β）完全激动剂，正在开发用于治疗代谢功能障碍相关脂肪性肝炎（MASH）和其他心代谢疾病。与部分激动剂不同，ECC4703 旨在提供更高的疗效，有可能实现更深层次的致动脉粥样硬化脂质降低、更大的肝脏脂肪清除以及对炎症和纤维化改善的有利作用。

In Phase 1 studies, ECC4703 demonstrated robust target engagement activities, including marked reductions in LDL-C..

在第一阶段研究中，ECC4703展示了强大的靶点参与活性，包括显著降低LDL-C。

About ECC0509

关于ECC0509

ECC0509 is a novel, once-daily, oral small molecule inhibitor of semicarbazide-sensitive amine oxidase (SSAO, also known as vascular adhesion protein-1 [VAP-1]), specifically engineered for high selectivity and minimal brain penetration. In a Phase 1 study, ECC0509 demonstrated dose-dependent inhibition of SSAO activity and significant changes in circulating methylamine, confirming target engagement.

ECC0509 是一种新型的、每日一次的口服小分子半卡巴肼敏感胺氧化酶（SSAO，又称血管黏附蛋白-1 [VAP-1]）抑制剂，专门设计用于实现高选择性和极小的脑渗透性。在一项 1 期研究中，ECC0509 展现出剂量依赖性的 SSAO 活性抑制，并引起循环甲胺的显著变化，证实了靶点结合。

ECC0509 is being developed both as a monotherapy for the treatment of osteoarthritis (OA) pain and in combination with ECC4703 for MASH..

ECC0509 正在作为单药治疗骨关节炎 (OA) 疼痛以及与 ECC4703 联合用于治疗 MASH 的开发中。

About Eccogene

关于Eccogene

Eccogene is a clinical-stage biopharmaceutical company developing next-generation oral small molecule therapeutics for cardiometabolic and inflammatory conditions. The Company’s diverse pipeline of small molecule candidates leverages its world-class expertise in translational research, small molecule drug discovery, and a deep understanding of cardiometabolic diseases.

Eccogene是一家临床阶段的生物制药公司，致力于开发用于心代谢和炎症疾病的下一代口服小分子疗法。公司多样化的小分子候选药物管线依托其在转化研究、小分子药物发现方面的世界级专业知识，以及对心代谢疾病的深刻理解。

For more information, please visit www.eccogene.com or follow the Company on LinkedIn..

欲了解更多信息，请访问www.eccogene.com或在LinkedIn上关注该公司。

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Source: globenewswire.com

来源：globenewswire.com