Biomarker and AI-supported FX06 therapy to prevent progression from mild and moderate to severe stages of COVID-19

More than 2.7 million hospitalisations of COVID-19-infected patients have occurred in Europe alone since the outbreak of the coronavirus in 2020. An average 14% of those patients with mild or moderate illness develop severe symptoms and are eventually admitted to the Intensive Care Unit (ICU). The most common treatment of patients in the first two stages of the illness, such as remdesivir and antibody therapies, have neither shown the desired effect nor prevented the progression of the disease to severe and critical stages of the illness. Interventions against SARS-CoV-2 are in high need to prevent admissions to ICUs, and would reduce the burden on patients and their families, clinical staff and the healthcare sector. Additionally, such interventions would help to provide ICU beds for non-Covid patients requiring immediate interventions, such as for heart or cancer surgery, both of which are often in need of planned free ICU beds. In COVend, our multidsciplinary consortium will deliver a new effective therapy against SARS-CoV-2 for the clinical management of the COVID-19 disease during mild and moderate stages, including for the prevention of disease progression to severe illness. This will be achieved by advancing a promising therapeutic candidate, FX06, from Technology Readiness Level (TRL) 7 to TRL9 through a multi-centre phase II/III clinical trial. COVend will study the influence of COVID-19 on endothelial cells (ECs) and the potential protective effect of FX06, and will apply -omics technologies, generate new algorithms and open-source software to carry out data analytics and modelling, and will develop health economic models to assess the socio-economic benefits and cost effectiveness of the new therapy. The COVend consortium unites expertise from different disciplines, including (cell) biology, ICT expertise for AI-based evaluations, pharma, economics and social sciences, as well as clinical expertise from 13 European countries.