Treatment of critical COVID-19 patients through removal of IL-6 by magnetic blood filtration

MediSieve is a multi-award-winning medical device company developing Magnetic Blood Filtration (MBF), an extracorporeal technology similar to dialysis, in which Targeted Magnetic Particles (TB-MPs) are infused into the extracorporeal loop, binding specifically to disease-relevant targets in the patient's blood. The blood then flows through a Magnetic Filter (MF) which captures the particles and bound targets, while the remainder of the blood returns to the patient unaffected. There are 6 TB-MPs currently under development, targeting IL-6, endotoxins, IL-1ß, IL-18, CD19 and CD20\. In this project, MediSieve proposes to accelerate the development of its anti-IL-6 TB-MPs and to apply MBF as a treatment to severe COVID-19 patients in the UK and worldwide. The project will support validation in animal trials and clinical trials, regulatory approvals, and lay the foundations for widespread distribution post-project.

COVID-19 studies have identified IL-6 driven hyperimmune reactions as a significant contributor to mortality with elevated IL-6 (p<0.0001) a predictor of fatality (Conti, J. Bio. Reg. Hom. Ag. 2020; Mehta, Lancet 2020). Additionally, a retrospective study of 191 hospitalised patients with COVID-19 found that over 50% developed sepsis (Zhou, Lancet 2020). By focusing specifically on IL-6 MediSieve can rapidly bring a product to market to alleviate the cytokine storm and hyperimmune reaction as well as the secondary sepsis that is the cause of significant mortality in COVID-19 patients. In vitro data suggest that adult IL-6 levels could be reduced by 90% in 4 hours. The MF has completed GLP pre-clinical animal studies and manufacturing validation; it is ready for first-in-man trials. The IL-6 TB-MPs have been validated with in vitro blood testing and are ready for animal trials. This project will accelerate development of the IL-6 TB-MPs and whole system through pre-clinical validation, manufacturing validation and regulatory approval to enable human clinical trials in preparation for full scale release.