Latest news with #VirTusRespiratoryResearchLtd
Business Wire
5 days ago
- Health
- Business Wire
Ethris Doses First Patient in Phase 2a Clinical Trial of Lead mRNA Candidate ETH47 for Asthma
MUNICH--(BUSINESS WIRE)-- Ethris GmbH, a clinical-stage biotechnology company pioneering next-generation RNA therapeutics and vaccines, today announced that the first patient has been treated in a Phase 2a clinical trial investigating ETH47, Ethris' lead mRNA-based antiviral candidate. The study will assess the ability of intranasal ETH47 to reduce asthma-related symptoms following a rhinovirus challenge in adults with asthma. ETH47 encodes interferon lambda (IFNλ), a protein crucial for viral immunity in the airways. It is designed to target viral triggers of asthma exacerbations, one of the most common causes of acute symptoms in patients with asthma. The start of the Phase 2a clinical trial (ISRCTN21576805) builds on positive data from the Phase 1 trial (ISRCTN15391202) where ETH47 demonstrated favorable safety and tolerability at all tested doses in healthy volunteers. The trial confirmed targeted activity in the respiratory tract, with robust local induction of IFNλ and activation of antiviral genes, with no systemic exposure to mRNA, IFNλ, or the lipidoid nanoparticle, thereby minimizing the risk of off-target effects. 'Dosing the first patient in our Phase 2a trial for ETH47 marks a defining moment for Ethris, as we advance our lead candidate further into clinical development and continue to validate the potential of Ethris' innovative platform,' said Dr. Thomas Langenickel, Chief Medical Officer of Ethris. 'ETH47 stands out as a highly promising candidate with a novel mechanism of action designed to directly strengthen the body's antiviral defenses in the airways. By targeting viral infections upstream, ETH47 has the potential to fundamentally change the way asthma is managed and reduce the burden of acute attacks. The trial gives us the opportunity to validate a new paradigm of care and, if successful, set a new standard for asthma treatment and open doors for broader advances in respiratory disease.' Sebastian Johnston, Professor of Respiratory Medicine at the Imperial College London and Director & Chief Medical Officer of VirTus Respiratory Research Ltd, an internationally recognized expert in the field of asthma and viral respiratory infections and one of Ethris' scientific advisors, added, 'After more than three decades investigating the role of respiratory viruses in asthma, it is clear that we need new approaches to address the underlying triggers of asthma exacerbations. Most therapies today focus on managing symptoms or reducing inflammation. There remains a significant unmet need for interventions that directly target viral triggers and boost antiviral defenses in the airways. This is precisely where innovative new approaches like ETH47 could make a real difference for patients and healthcare systems.' The Phase 2a clinical trial is a randomized, double-blind, placebo-controlled study being conducted by VirTus Respiratory Research Ltd at St. Mary's Hospital, London, UK. It will enroll 50 adult patients with asthma who will undergo a rhinovirus challenge and will then be equally randomized to receive either ETH47 or placebo. The primary endpoint will evaluate the impact of ETH47 on respiratory symptoms, as measured by the Lower Respiratory Symptoms Score (LRSS) – a commonly used, standardized survey completed by participants twice daily. The primary objective is to assess whether ETH47 can help restore respiratory health in asthmatic patients, bringing them closer to the level observed in healthy individuals. After the successful completion of this trial, Ethris plans to progress ETH47 into a broader Phase 2b study, further evaluating its potential to reduce asthma exacerbations and improve patient outcomes. About 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®RNA) platform, and uniquely designed to be administered locally to the respiratory tract through inhalation or nasal spray using Ethris' proprietary Stabilized NanoParticle (SNaP®) 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. About 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 platform 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 optimised formulation and nebulisation technologies. 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.
Business Wire
08-05-2025
- Health
- Business Wire
VirTus Respiratory Research Ltd的人体鼻病毒攻毒模型研究结果推动Altesa BioSciences的主导药物进入高级临床试验阶段
伦敦--(BUSINESS WIRE)--(美国商业资讯)-- 专注呼吸系统研究的知名合同研究公司VirTus Respiratory Research Ltd今日宣布，其针对慢性阻塞性肺疾病（COPD）患者开展的鼻病毒人体攻毒模型研究结果，为Altesa BioSciences提供了关键证据，支持将其主导候选药物vapendavir推进至大规模后期临床试验阶段。 鼻病毒感染是导致数百万慢性阻塞性肺病患者出现急性呼吸功能恶化的主要原因，占比至少50%。Altesa首席执行官、美国前卫生部助理部长兼FDA代理局长Brett Giroir博士表示，'在投入数千万美元将vapendavir推进至涉及数千名患者的临床试验之前，通过概念验证研究证实该药物的疗效至关重要。经过全球范围的严格筛选，我们确认VirTus是唯一能够安全、有效且可靠地在真实COPD志愿者中开展此项研究的机构。' 这项随机、安慰剂对照研究招募并评估了40名慢性阻塞性肺病（COPD）志愿者，COPD是全球第三大死亡原因。经过预先筛查的COPD受试者在接种已知安全型鼻病毒毒株后，于症状出现时完成随机分组。本次研究将精准社交媒体推广作为主要招募渠道，触达逾万名潜在志愿者，这一创新性招募策略充分彰显了VirTus为确保受试者高效入组所采用的先进方法。 VirTus联合创始人兼首席医疗官Sebastian Johnston教授表示，'这些积极成果印证了我们人体病毒攻毒模型能够有效地在新药临床研发早期快速评估疗效。该方法能让生物科技和制药合作伙伴获得具有临床意义的早期数据，帮助他们在药物研发管线中做出可靠的继续/终止决策。' VirTus人体病毒攻毒模型为临床试验主办方提供了在受控环境下评估治疗方案的机会，与传统的大规模早期临床开发研究相比，可显著降低不确定性并大幅缩减时间和成本。 Altesa首席医学官、GSK前首席医学官Kate Knobil博士表示，'借助Johnston教授及VirTus团队的丰富经验，我们已掌握如何最优使用vapendavir，使其最大程度改善COPD患者的生活质量——这正是我们矢志追求的终极目标，也是我毕生职业生涯的奋斗方向。' VirTus联合创始人兼董事总经理Michael Edwards博士补充道，'我们非常荣幸能支持Altesa BioSciences取得vapendavir的这些鼓舞性成果。此次成功合作彰显了我们人体攻毒研究的优势与可靠性，进一步强化了我们加速全球呼吸道疾病创新疗法开发的使命。' 关于VirTus Respiratory Research Ltd VirTus Respiratory Research Ltd是由英国帝国理工学院Sebastian Johnston教授与Michael Edwards博士共同领导的合同研究组织（CRO）。VirTus专注于加速呼吸道病毒感染治疗与预防新疗法的开发——这类感染正是哮喘、慢性阻塞性肺疾病（COPD）及支气管扩张等慢性呼吸系统疾病急性发作的首要诱因。VirTus开展从临床前到早期阶段的临床研究，其专长的人体病毒攻毒模型可生成高质量数据，为创新疗法推进至后期研发阶段提供关键支持。 鼻病毒攻毒模型 VirTus Respiratory Research Ltd使用鼻病毒攻毒模型在严格受控、可重复的实验环境中，产生药物临床疗效的早期信号。该模型通过对志愿者实施监测条件下的鼻病毒感染，可全面评估治疗方案对症状、病毒载量及免疫/炎症反应的影响。对合作伙伴而言，这一模型是在开展规模更大、成本更高的IIb/III期试验前至关重要的"继续/终止"决策工具。它能在早期解答包括临床疗效、剂量选择和终点指标优化等关键问题。主办方可借此缩短研发周期、提前获得'继续/终止'决策依据，通过在早期阶段识别有潜力的候选药物或排除无效方案来降低研发风险，最终实现资源优化配置并提高后续研发成功率。 关于Vapendavir 口服片剂vapendavir是一款处于临床阶段的抗病毒药物，对97%的测试鼻病毒株及其他呼吸道肠道病毒均表现出强效活性。该药物通过双重作用机制起效：既能阻断病毒侵入人体细胞，又可抑制病毒复制。目前，Vapendavir针对COPD患者鼻病毒感染的适应症已进入后期临床试验阶段。其作用机制与Gilead Sciences已获FDA批准的HIV衣壳抑制剂lenacapavir类似。 关于COPD 慢性阻塞性肺疾病（COPD）是一种影响全球数亿患者的致命性慢性肺部疾病。作为当前全球第三大死因，COPD患病率随着人口老龄化及持续暴露于吸烟、空气污染等风险因素而不断攀升。该疾病给患者个体和医疗系统均带来沉重负担：一方面因进行性肺功能衰退和频繁急性加重导致高发病率；另一方面长期治疗及反复住院产生的巨额医疗费用（仅美国每年就高达490亿美元）也造成巨大经济压力。 关于Altesa Altesa BioSciences是一家临床阶段制药公司，致力于为人类健康长期面临的重大威胁——高致病性病毒感染，开发新型疗法。这类感染对脆弱人群的影响尤为严重，包括肺部疾病等慢性病患者、老年人以及医疗服务不足社区的众多群体。 免责声明：本公告之原文版本乃官方授权版本。译文仅供方便了解之用，烦请参照原文，原文版本乃唯一具法律效力之版本。
