ERICA: Evaluation of the Role of Inflammation in non pulmonary disease manifestations in Chronic Airways disease (COPD)

该项目由三个要素组成，旨在确定纤维蛋白原识别具有肌肉和/或心血管疾病表现的COPD患者的能力。第一部分的重点是支持代表COPD非肺部疾病亚型的临床生物标志物的监管接受，旨在确保我们产品组合中的资产不会因不适当的临床开发计划而被丢弃。第二部分包括一项在选定的血液纤维蛋白原升高的COPD患者亚组中使用新型II期抗炎药的临床试验，以评估其对我们选择的临床生物标志物的影响。第三部分是一项实验性医学研究，使用了一种具有前所未有的作用机制的I期新药候选药物，与其他两部分一起，可能为有心血管相关事件风险的COPD患者提供一种新的治疗方法。

The project consists of three elements and seeks to determine the ability of fibrinogen to identify patients with COPD who have muscle and/or cardiovascular disease manifestations. The first part is focused on supporting Regulatory acceptance of clinical biomarkers representing the non-pulmonary disease subtype of COPD with the aim to ensure that assets in our Portfolio are not discarded due to an inappropriate clinical development plan. The second part includes a clinical trial with a novel Phase II anti-inflammatory in a selected subset of COPD patients with elevated blood fibrinogen to assess its effect on our chosen clinical biomarkers. The third part is an experimental medicine study with a Phase I novel drug candidate with an unprecedented mechanism of action which, together with the 2 other parts, may provide a path for a novel therapy for COPD patients at risk of cardiovascular-related events.