Preventing asthma exacerbations by reducing viral respiratory infections

描述(申请人提供)：据估计，全世界有3亿人患有哮喘，每年导致多达250,000人死亡1.哮喘是一种个人和公共、健康和经济负担，即使在发达国家，也有近10%的人口失去了大量离开工作和上学的时间。导致哮喘恶化的主要原因是呼吸道病毒感染，占70%以上。Pulmotect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，它刺激肺部自身的固有防御机制，为病原体创造一个敌对的环境，可以预防或减轻呼吸道感染。这项技术已经通过了体外和体内实验的验证，该药物已经在调节过程中取得进展，作为一种在免疫妥协期间造福癌症患者的治疗方法。在目前的提案中，我们提出了实现里程碑的计划，这些里程碑将通过1)展示PuL-042在小鼠哮喘模型中的直接益处以及2)进行关键的开发活动来支持哮喘患者的临床试验，从而推动这项技术在哮喘市场上的商业化。该项目被组织成提案中描述的六个可衡量的具体目标。

DESCRIPTION (provided by applicant): An estimated 300 million people worldwide are affected by asthma, causing up to 250,000 deaths per year1,2. Asthma is a personal and public, health and economic burden even in developed countries, where nearly 10% of the population loses substantial time away from work and school. The principal cause of asthma exacerbations, responsible for more than 70%3, is viral respiratory infections. Pulmotect is developing a novel technology to prevent respiratory infections. The lead drug (PUL-042) is a combination of two TLR ligands that stimulates the lungs own innate defense mechanisms, creating a hostile environment for pathogens that can prevent or attenuate respiratory infections. This technology has been validated by both in vitro and in vivo experiments and the drug is already progressing in the regulatory process as a treatment to benefit cancer patients during periods of immunocompromise. In the current proposal, we present plans to accomplish milestones that will advance this technology for commercialization for the asthma market by 1) showing the direct benefit of PUL-042 in mouse asthma models and 2) conducting key development activities to support a clinical trial in patients with asthma. The project is organize into six measurable Specific Aims described in the proposal.