ARDS is a significant medical issue with no currently available drug-based treatments. It can occur due to various factors, such as viral or bacterial infections, severe trauma, major surgery, or blood transfusions. In ARDS patients, the exchange of gases in the lungs is hindered by damaged alveoli, dysfunctional capillaries, and fluid build-up. The surface of our blood vessels is lined by endothelial cells that function as important regulators of vascular homeostasis controlling immune competence, inflammatory equilibrium, blood coagulation and other essential vital functions of the cardiovascular system. Viral infection induces damage of the endothelium and results in an auspicious spiral that may lead to capillary leakage, thrombosis, ARDS, and multiorgan failure ultimately manifesting in high morbidity and mortality. Thus, understanding and counteracting the disease in this context is crucial to improve patient outcomes. FX06 operates as an endothelium-protective drug and may prevent detrimental host inflammatory responses including endotheliitis, hyperinflammation, and hypercytokinemia (better known as cytokine storm). Strikingly, it does not rely on host-virus interactions and thus acts independently of any viral mutations. FX06 does not manipulate the host metabolism or immune system and is in general well tolerated. The COVend Project aims to develop an FX06 precision therapy for the clinical management ARDS of different etiology, focusing on the prevention of disease progression to severe illness. The main objective is to test the therapeutic candidate FX06 in a placebo-controlled, double-blind, randomised, multi-national phase II clinical trial. COVend brings together clinicians, biochemists, data scientists, and economists to gain a comprehensive understanding of ARDS and identify effective treatment strategies for real-world scenarios. IXION2.0 is being conducted in 5 European countries (France, Germany, Lithuania, Romania and Spain) and is open to patients of all genders and all ethnicities, ensuring a diverse study population representative for all European citizens. The main project goals include preparing and distributing the investigational medicinal product (IMP), conducting the clinical trial, investigating the molecular profile of COVID-19 and its change upon FX06 treatment, creating additional solid evidence based on sophisticated in vitro studies with endothelial cell lines, developing biomarkers and open source decision support applications for an FX06 precision therapy, and evaluating the health-economic benefits and cost-effectiveness of this therapy. Based on the scientific knowledge gained in COVend and IXION2.0 we aim to aid patients with ARDS related to COVID-19 or other aetiologies and contribute to a society that is prepared for future disease outbreaks.
