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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.
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