Pneumoreductive Surfactant Therapy for Emphysema

肺气肿的气动表面活性剂治疗

• 批准号: 7785876
• 负责人: EDWARD P INGENITO
• 金额: $ 32.09万
• 依托单位: AERIS THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-20 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7785876
• 关键词: Advanced Development; Animals; Breathing; Chronic Obstructive Airway Disease; Clinical Protocols; Clinical Treatment; Contracts; Data; Development; Dose; Drug Formulations; Effectiveness; Evaluation; Funding; Guanosine Monophosphate; Human; In Vitro; Lung; Manufactured Materials; Medical; Methods; Nebulizer; Patients; Pharmaceutical Preparations; Pharmacodynamics; Phase; Phase I Clinical Trials; Plants; Preparation; Principal Investigator; Procedures; Property; Pulmonary Emphysema; Pulmonary Surfactants; Research Design; Safety; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Source; Surface Tension; System; Testing; Therapeutic; Toxic effect; Validation; Week; Work; commercialization; improved; in vivo Model; novel; novel therapeutics; programs; research clinical testing; response; scale up; surfactant; therapy design

DESCRIPTION (provided by applicant): Aeris therapeutics is developing a novel medical treatment for patients with advanced emphysema known as Pneumoreductive Surfactant (PRS). PRSs are inhaled drugs that increase lung recoil by safely altering the surface tension properties of native lung surfactant. Unlike existing medical therapies for chronic obstructive pulmonary disease, PRS is the only medical therapy designed specifically to treat emphysema by improving lung recoil and decreasing hyperinflation. During Phase I SBIR funding (9/2004 to 3/2005), Aeris identified two PRS formulations that favorably alter lung surfactant function in vitro, and effectively increase lung recoil in emphysema models in vivo. The best of these preparations has been selected for product development. Dose-response and dose delivery studies demonstrate that PRSs can be effectively delivered to the lung using conventional nebulizer systems. Repeat dosing studies confirm the safety of PRS administration, out to two weeks. GMP sources of raw materials for manufacturing PRS have been identified, and a manufacturing protocol, clinical plan, and regulatory strategy have been developed for advancing this product into clinical testing. Aeris is requesting Phase II SBIR support to advance the development of this exciting new therapeutic product.

描述（由申请人提供）：AERIS Therapeutics正在针对被称为肺炎表面活性剂（PRS）的晚期肺气肿患者开发一种新型的医学治疗。 PRS是吸入的药物，可通过安全地改变天然肺表面活性剂的表面张力特性来增加肺后坐力。与现有的慢性阻塞性肺疾病的医学疗法不同，PRS是唯一一种专门用于通过改善肺后退和减少过度充气的治疗肺气肿的药物疗法。在I期SBIR资金（9/2004至3/2005）期间，Aeris确定了两种PRS制剂，可在体外改变肺表面活性剂功能，并有效地增加体内肺气肿模型中的肺后退。这些制剂中最好的选择已被选为产品开发。剂量反应和剂量递送研究表明，可以使用常规的雾化器系统有效地将PRS传递到肺中。重复给药研究证实了PRS给药的安全性，直到两周。已经确定了用于制造PRS的原材料的GMP来源，并制定了制造方案，临床计划和监管策略，以将该产品推进到临床测试中。 Aeris要求II期SBIR支持，以推动这种令人兴奋的新治疗产品的开发。