A magnetic filter outside the body could strip a dangerous inflammatory protein from the blood of critically ill COVID-19 patients within hours. The problem is that many severe COVID-19 deaths are driven by a cytokine storm—a hyperimmune reaction where the immune signalling molecule IL-6 surges to lethal levels. Over half of hospitalised COVID-19 patients also develop sepsis. Existing drugs that block IL-6 can help, but they act slowly and affect the whole body. MediSieve’s approach is more direct: blood is diverted through a machine, mixed with magnetic particles that latch onto IL-6, then passed through a magnetic filter that pulls out the particles and their bound cargo. Lab data suggest this could cut adult IL-6 levels by 90% in four hours. If clinical trials succeed, the device could become a rapid, targeted treatment for cytokine storms not only in COVID-19 but also in sepsis, autoimmune diseases, and other conditions where specific blood-borne molecules drive illness. The company already has six types of magnetic particles in development, targeting different disease markers. The filter itself has passed animal safety studies and is ready for first human trials.
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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.
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