Preventing asthma exacerbations by reducing viral respiratory infections

描述（由申请人提供）：哮喘是全球呼吸系统疾病的主要原因，估计每年有3亿人受影响，多达250，000人死亡。即使在发达国家，哮喘仍然是近10%人口的负担，工作和学校损失了大量时间以及相当大的医疗保健支出。哮喘恶化的主要原因是病毒性呼吸道感染，估计占70%以上。Pulmotect的解决方案：Pulmotect已经确定并正在开发一种预防呼吸道感染的新技术。先导药物（PUL-042）是两种TLR配体的组合，可刺激肺部自身的先天防御机制，为病原体创造一个不利的环境，预防或减轻呼吸道感染。已经完成了体外和体内实验来验证这项技术，并且该药物正在通过监管过程进行治疗，以使免疫受损期间的癌症患者受益。该提案的重点是实现关键里程碑，通过显示PUL-042在小鼠哮喘模型中的直接益处，进一步将该技术过渡到哮喘市场的商业化。该项目分为三个可衡量的具体目标，包括评估PUL-042在哮喘小鼠模型中的安全性和有效性。 公共卫生相关性：Pulmotect公司正在开发新的疗法，刺激先天免疫系统，以防止感染性疾病，即使在免疫力严重受损的情况下。概念验证数据表明，该技术有效地防止了广泛的吸入性病原体。该项目将提供重要的数据，以帮助将这项技术从实验室转移到哮喘患者的诊所。这项工作将利用正在进行的活动，为癌症患者开发技术。

DESCRIPTION (provided by applicant): Asthma is a leading cause of respiratory disease worldwide, with an estimated 300 million people affected and up to 250,000 deaths per year. Even in developed countries, asthma continues to be a burden for nearly 10% of the population with substantial time lost from work and school and considerable health care expenditures. The principal cause of asthma exacerbations is viral respiratory infections, estimated to be responsible for more than 70%. Pulmotect's Solution: Pulmotect has identified and is developing a novel technology to prevent respiratory infections. The lead drug (PUL-042) is a combination of two TLR ligands that stimulates the lung's own innate defense mechanisms to create a hostile environment for pathogens and prevent or attenuate respiratory infections. Both in vitro and in vivo experiments have been completed to validate this technology and the drug is progressing through the regulatory process for a treatment to benefit cancer patients during periods of immunocompromise. The focus of this proposal is to accomplish key milestones that will further transition this technology for commercialization for the asthma market by showing the direct benefit of PUL-042 in mouse asthma models. The project is organized into three measurable Specific Aims that include evaluating the safety and efficacy of PUL-042 in a mouse models of asthma. PUBLIC HEALTH RELEVANCE: Pulmotect, Inc is developing novel therapeutics that stimulate the innate immune system to protect against infectious diseases, even in cases of severely compromised immunity. Proof-of-concept data has shown that this technology effectively protects against a broad range of inhaled pathogens. This project will provide significant data to help transition this technology from the lab to the clinic for asthmatics. This work will leverage ongoing activities in developing the technology for cancer patients.