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Ethris GmbH

Ethris 有限公司

, a leading biotechnology company pioneering next-generation RNA therapeutics and vaccines, today announced promising topline data from the completed Phase 1 clinical trial of its lead mRNA therapeutic candidate, ETH47, in healthy volunteers. Designed to address the upstream trigger of asthma exacerbations, ETH47 encodes interferon lambda (IFNλ), a protein essential for viral immunity in the respiratory tract.

，一家领先的生物技术公司，开创了下一代RNA治疗和疫苗，今天宣布了有希望的topline数据，该数据来自其主要mRNA治疗候选物ETH47在健康志愿者中完成的1期临床试验。ETH47编码干扰素λ（IFNλ），这是一种对呼吸道病毒免疫至关重要的蛋白质，旨在解决哮喘恶化的上游触发因素。

These topline results provide the first clinical validation of Ethris’ pioneering targeted RNA therapeutic approach and its ability to induce a downstream cascade of antiviral interferon-stimulated genes locally following nasal administration. Thomas Langenickel, MD, Chief Medical Officer at Ethris, presented the results on January 30.

这些topline结果为Ethris开创性的靶向RNA治疗方法及其在鼻腔给药后局部诱导抗病毒干扰素刺激基因下游级联的能力提供了首次临床验证。1月30日，Ethris首席医疗官、医学博士ThomasLangenickel介绍了研究结果。

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, 2025, at the mRNA-Based Therapeutics Summit Europe in Frankfurt, Germany.

，2025年，在德国法兰克福举行的基于mRNA的欧洲治疗峰会上。

“These positive Phase 1 results reinforce the promise of ETH47 as a potentially safe and transformative treatment option for asthma patients, while also validating our SNIM

“这些积极的第一阶段结果强化了ETH47作为哮喘患者潜在安全和变革性治疗选择的前景，同时也验证了我们的SNIM

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and SNaP

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proprietary technology platforms as a viable delivery option for mRNA therapeutics to the respiratory tract,” said Dr. Thomas Langenickel, Chief Medical Officer at Ethris. “This significant milestone demonstrates the ability of our technology to deliver precisely designed mRNA candidates to the respiratory tract, facilitating production of the encoded protein and engagement with the intended target.

Ethris首席医疗官Thomas Langenickel博士说：“专有技术平台是将mRNA治疗剂输送到呼吸道的可行选择。这一重要里程碑证明了我们的技术能够将精确设计的mRNA候选物输送到呼吸道，促进编码蛋白的产生和与预期目标的接触。

With this strong foundation, we look forward to advancing ETH47 into Phase 2 trials in 2025 and remain committed to exploring its potential to transform care for patients with asthma and broader respiratory conditions.”.

有了这个坚实的基础，我们期待着在2025年将ETH47推进到第二阶段试验，并继续致力于探索其改变哮喘患者和更广泛呼吸系统疾病患者护理的潜力。”。

The Phase 1 study assessed the safety, tolerability, and target engagement of ETH47 after nasal administration in 40 healthy participants.

第一阶段研究评估了40名健康参与者鼻腔给药后ETH47的安全性，耐受性和目标参与度。

Key Results from the Phase 1 Study:

第一阶段研究的主要结果：

Safety and tolerability: ETH47 was generally safe and well tolerated across all dose levels, with no serious or severe adverse events and no adverse events leading to discontinuation reported in the healthy participants. The study also demonstrated no systemic bioavailability of the mRNA, the produced protein IFNλ, or the proprietary lipidoid compound, minimizing the risk of off-target effects..

安全性和耐受性：ETH47在所有剂量水平上通常是安全的并且耐受性良好，没有严重或严重的不良事件，并且在健康参与者中没有报告导致停药的不良事件。该研究还表明，mRNA，产生的蛋白质IFNλ或专有类脂质化合物没有全身生物利用度，从而最大程度地降低了脱靶效应的风险。。

Dose-dependent target engagement: ETH47 exhibited a clear dose-dependent production of IFNλ in the nasal lining fluid exceeding predicted therapeutic levels. ETH47 administration also activated the mRNA expression of antiviral interferon-stimulated genes (ISGs) in nasal brush samples. These findings confirm ETH47’s pharmacodynamic activity and support its proposed mechanism of action..

剂量依赖性靶标参与：ETH47在鼻衬液中表现出明显的剂量依赖性IFNλ产生，超过了预测的治疗水平。ETH47给药还激活了鼻刷样品中抗病毒干扰素刺激基因（ISG）的mRNA表达。。。

Based on the encouraging Phase 1 results, Ethris filed a Clinical Trial Application (CTA) for a Phase 2a rhinovirus challenge study in asthma patients, planned to begin in Q2 2025. This upcoming trial will focus on evaluating the ability of ETH47 to reduce lower respiratory symptoms in asthma patients following rhinovirus infection..

基于令人鼓舞的第一阶段结果，Ethris提交了一份临床试验申请（CTA），用于哮喘患者的2a期鼻病毒攻击研究，计划于2025年第二季度开始。这项即将进行的试验将重点评估ETH47在鼻病毒感染后减轻哮喘患者下呼吸道症状的能力。。

About ETH47

关于ETH47

ETH47 is Ethris’ first-in-class mRNA-based product candidate encoding interferon lambda (IFNλ) that was developed using the company’s Stabilized Non-Immunogenic mRNA (SNIM

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RNA) platform, and uniquely designed to be administered locally to the respiratory tract through inhalation or nasal spray using Ethris’ proprietary Stabilized NanoParticle (SNaP

RNA）平台，独特设计，可通过吸入或鼻喷雾剂使用Ethris专有的稳定纳米颗粒（SNaP）局部给予呼吸道

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) LNP platform. ETH47 is meant to induce a mucosal innate immune defense response at virus entry sites as well as inhibit viral replication. ETH47’s versatile, virus- and mutation-independent mode of action has the potential to broadly address seasonal and emerging respiratory virus infections, including virus-driven exacerbation of chronic respiratory diseases such as asthma..

)LNP平台。ETH47旨在诱导病毒进入位点的粘膜先天免疫防御反应，并抑制病毒复制。ETH47的多功能，不依赖病毒和突变的作用模式有可能广泛解决季节性和新出现的呼吸道病毒感染，包括病毒驱动的慢性呼吸道疾病（如哮喘）的恶化。。

About Uncontrolled Asthma

关于不受控制的哮喘

Uncontrolled asthma is a significant burden for patients, including 4.4 million moderate to severe asthma patients in the US alone. Approximately 80% of acute asthma attacks (exacerbations) are associated with virus infections. Asthma exacerbations cause excessive inflammation and mucus hyperproduction.

不受控制的哮喘是患者的重大负担，仅在美国就有440万中度至重度哮喘患者。大约80%的急性哮喘发作（恶化）与病毒感染有关。哮喘恶化会导致过度炎症和粘液过度产生。

They remain a significant burden for patients, leading to increased healthcare costs and decreased quality of life. ETH47’s innovative mechanism of action aims to prevent those exacerbations at their source, potentially improving outcomes for millions of patients worldwide..

它们仍然是患者的重大负担，导致医疗费用增加和生活质量下降。ETH47的创新行动机制旨在从源头上防止这些恶化，从而有可能改善全球数百万患者的预后。。

About Ethris

关于Ethris

Ethris, a clinical-stage biotechnology company, has paved a new path from genes to therapeutic proteins, using its proprietary RNA and lipidoid nanoparticle technology platforms to discover, design and develop innovative therapies. With more than a decade as an mRNA pioneer, Ethris is a global leader in delivering stabilized mRNAs directly to the respiratory system via optimized formulation and nebulization technologies.

Ethris是一家临床阶段的生物技术公司，利用其专有的RNA和类脂质纳米粒子技术平台，发现、设计和开发创新疗法，为从基因到治疗性蛋白质铺平了新的道路。Ethris作为mRNA先驱已有十多年的历史，是通过优化配方和雾化技术将稳定的mRNA直接输送到呼吸系统的全球领导者。

The company is rapidly advancing its mRNA pipeline of immuno-modulation, protein replacement therapies, and differentiated vaccines, with the ultimate goal of improving patients’ lives..

该公司正在迅速推进其免疫调节、蛋白质替代疗法和分化疫苗的mRNA管道，最终目标是改善患者的生活。。

For more information, visit

有关更多信息，请访问

www.ethris.com

www.ethris.com