ENA Respiratory宣布发表支持其新型鼻腔内疗法INNA-051减少老年人病毒性呼吸道感染影响的潜力的出版物-动脉网

ENA Respiratory Announces Publication Supporting the Potential of its Novel Intranasal Therapy INNA-051 to Reduce the Impact of Viral Respiratory Infections in Older Adults

GlobeNewswire 等信源发布 2025-04-02 04:00

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Clinical studies demonstrated that INNA-051’s natural defence boosting mechanism is effective in older adults

临床研究表明，INNA-051 的天然防御增强机制对老年人有效。

Administration of INNA-051 to older adults (65 years old) in a Phase 1 study was well-tolerated and increased important antiviral host-defence pathways

在一期研究中，向老年人（65岁）施用INNA-051后，耐受性良好，并增强了重要的抗病毒宿主防御途径。

Pre-clinical data demonstrated reduced influenza virus dissemination to the lungs of aged mice, consistent with results from studies in younger animals

临床前数据显示，老年小鼠肺部流感病毒的传播减少，这与年轻动物研究的结果一致。

Data published in ERJ Open Research, a leading open access journal in respiratory medicine

发表在呼吸医学领域领先的开放获取期刊《ERJ Open Research》上的数据

MELBOURNE, Australia, April 02, 2025 (GLOBE NEWSWIRE) --

澳大利亚墨尔本，2025年4月2日（环球新闻社）--

ENA Respiratory

ENA呼吸系统

, a clinical-stage pharmaceutical company developing antiviral host defence enhancers to minimize the impact of viral respiratory infections, announces today the early view publication of results of a Phase I extension study in older adults (66-80) of its liquid formulation of INNA-051, a novel TLR2/6 agonist, in ERJ Open Research, a leading research journal of the European Respiratory Society.

，一家临床阶段的制药公司，正在开发抗病毒宿主防御增强剂以减轻病毒性呼吸道感染的影响，今天宣布了其液体配方INNA-051（一种新型TLR2/6激动剂）在老年人（66-80岁）中的I期扩展研究结果的早期发表，该文章发布于欧洲呼吸学会的权威研究期刊《ERJ Open Research》。

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In a placebo-controlled dose-escalation Phase 1 study, a cohort of healthy older volunteers (66 – 80 years) received repeated intranasal doses of INNA-051. Biomarker analysis showed that INNA-051 triggered host defence pathways within eight hours of each dose. INNA-051 was also well-tolerated.

在一项安慰剂对照的剂量递增 I 期研究中，一组健康的年长志愿者（66-80 岁）接受了多次鼻腔内注射 INNA-051。生物标志物分析显示，INNA-051 在每次给药后的八小时内触发了宿主防御途径。INNA-051 也具有良好的耐受性。

The publication also includes supportive preclinical data. Dosing of INNA-051 in aged mice challenged with H3N2 seasonal influenza virus was shown to stimulate natural nasopharyngeal host defences and resulted in reduced viral dissemination to the lungs.

该出版物还包括支持性的临床前数据。对接受H3N2季节性流感病毒挑战的老年小鼠使用INNA-051进行给药，被证明可以刺激天然的鼻咽宿主防御，并减少病毒向肺部的扩散。

Ruth Tal-Singer PhD, Medicine Development Leader (Consultant) at ENA Respiratory, said:

露丝·塔尔-辛格博士，ENA呼吸公司的药物开发负责人（顾问），表示：

“These newly published results form part of a growing body of data supporting the potential of INNA-051 as a new virus-agnostic approach to protecting people from significant morbidity and mortality resulting from respiratory viral infections. Increased age is a major risk factor for such infections and these data demonstrate that INNA-051 is well-tolerated in an older population and stimulates natural host defence pathways in the nose aiming to provide rapid clearance of respiratory viruses which may prevent severe disease.”.

“这些新发布的结果构成了支持 INNA-051 作为一种新的与病毒无关的方法，保护人们免受呼吸道病毒感染导致的重大疾病和死亡的潜力的数据体系的一部分。年龄增长是此类感染的主要风险因素，而这些数据表明 INNA-051 在老年人群中具有良好的耐受性，并刺激鼻腔内的天然宿主防御途径，旨在快速清除呼吸道病毒，从而可能预防严重疾病。”

ENA will soon report the full results of a recently completed Phase 1b study of a more stable dry powder formulation in adults aged 18-80 years. Headline results demonstrate that INNA-051 was well-tolerated in all age groups and led to local activation of host defence pathways. This study provides further evidence for INNA-051 development in a broad age range..

ENA即将报告最近完成的一项针对18-80岁成年人更稳定的干粉制剂的1b期研究的完整结果。头条结果显示，INNA-051在所有年龄组中均具有良好的耐受性，并激活了宿主防御途径。该研究为INNA-051在广泛年龄范围内的开发提供了进一步证据。

ENA is planning to initiate a Q4 2025 Phase II community infection study in the US to assess the potential efficacy of INNA-051 to reduce the incidence, severity and duration of symptomatic infections caused by common respiratory viruses, including coronaviruses, seasonal influenza, rhinoviruses, respiratory syncytial virus and human metapneumovirus..

ENA计划于2025年第四季度在美国启动第二阶段社区感染研究，以评估INNA-051在减少由常见呼吸道病毒（包括冠状病毒、季节性流感、鼻病毒、呼吸道合胞病毒和人类偏肺病毒）引起的症状感染的发生率、严重程度和持续时间方面的潜在功效。

1. ERJ Open Research 2025 01044-2024; DOI:

1. ERJ开放研究 2025 01044-2024；DOI:

https://doi.org/10.1183/23120541.01044-2024

About ENA Respiratory

关于ENA呼吸系统

ENA Respiratory is a clinical-stage pharmaceutical company tackling respiratory viral infections through the development of host defence enhancers which locally prime and boost the body’s natural first line of defence against invading pathogens. Being virus-agnostic, ENA’s approach offers a solution to protect against common and emerging respiratory viruses for which vaccines or direct-acting antivirals have limitations or do not exist..

ENA Respiratory是一家临床阶段的制药公司，致力于通过开发宿主防御增强剂来应对呼吸道病毒感染，这些增强剂能够局部激发和增强人体对入侵病原体的自然第一道防线。ENA的方法不针对特定病毒，为防护常见和新兴的呼吸道病毒提供了解决方案，尤其针对那些疫苗或直接作用抗病毒药物存在局限性或尚未问世的病毒。

The company’s lead product, INNA-051, is being developed as a convenient, once-a-week nasal dry powder product to reduce the impact of viral respiratory infections and prevent severe complications in at-risk populations, including the elderly, those with an underlying medical condition (including chronic lung conditions, diabetes, kidney disease, and cardiovascular disease) and individuals with occupational risk (e.g.

该公司的主要产品 INNA-051 正在开发为一种便捷的每周一次鼻用干粉制剂，旨在减轻病毒性呼吸道感染的影响，并预防高风险人群（包括老年人、有基础疾病的人群（如慢性肺病、糖尿病、肾病和心血管疾病患者）以及有职业风险的个体（例如...））出现严重并发症。

first responders, military or essential services personnel)..

急救人员、军人或必要服务人员）。

INNA-051 is a potent agonist of toll-like receptor 2/6 (TLR2/6) which plays a key role in recognising pathogens and potentiating innate immune responses. With a safety profile supporting seasonal prophylaxis use, it has demonstrated accelerated virus clearance and stimulation of antiviral host defences, including IFN Type I & III responses, in a Phase IIa proof-of-principle study using a human influenza-challenge model..

INNA-051是一种有效的Toll样受体2/6（TLR2/6）激动剂，它在识别病原体和增强先天免疫反应中起关键作用。其安全性支持季节性预防使用，在一项使用人类流感挑战模型的IIa期原理验证研究中，已证明能够加速病毒清除并刺激抗病毒宿主防御，包括I型和III型干扰素反应。

Headquartered in Melbourne, Australia, the company has raised US$33 million (AU$46 million) in financing from Brandon Capital, The Minderoo Foundation, Flu Lab and Uniseed. It is partnered with the US COPD Foundation to support patient-centered clinical development of INNA-051 in COPD and has been awarded a US$13.1 million contract from the U.S.

总部位于澳大利亚墨尔本的该公司已从布兰登资本、明德罗基金会、流感实验室和尤尼西德筹集了3300万美元（4600万澳元）的融资。该公司与美国慢性阻塞性肺病基金会合作，支持INNA-051在慢性阻塞性肺病中的以患者为中心的临床开发，并获得了美国1310万美元的合同。

Department of Defense. It is an alumni member of BLUE KNIGHT™, a joint initiative between Johnson & Johnson Innovation and BARDA designed to accelerate novel potential solutions for future pandemics..

国防部。它是BLUE KNIGHT™的校友成员，该组织是由强生创新与BARDA联合发起的一项计划，旨在加速未来大流行病的潜在新型解决方案。

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