Two UK drugs companies will be the first to partner with the Universities of Birmingham and Oxford as part of a major new UK drugs trial to test potential therapeutics to treat patients hospitalised with COVID-19.
In what could be a significant development in the fight against the virus the CATALYST trial, which is a collaboration with University Hospitals Birmingham NHS Foundation Trust (UHB), will test a series of new drugs, including those already in use for patients with cancer and inflammatory diseases such as rheumatoid arthritis.
Designed by the Inflammation – Advanced and Cell Therapy Trials Team (I-ACT) at the University of Birmingham’s Cancer Research UK Clinical Trials Unit, the trial is being run in close partnership with UHB and the Birmingham National Institute for Health Research Biomedical Research Centre (NIHR BRC) and delivered in close collaboration with the Oxford and University College London NIHR BRC’s.
Oxford based biopharmaceutical company Izana Bioscience will provide the first of four potential treatments to be tested. Namilumab (IZN-101) is a fully human monoclonal antibody already in late-stage trials to treat rheumatoid arthritis and an inflammatory disease called ankylosing spondylitis. It targets a ‘cytokine’ called GM-CSF (granulocyte-macrophage colony stimulating factor), which is naturally secreted by immune cells in the body but, in uncontrolled levels, is believed to be a key driver of the excessive and dangerous lung inflammation seen in COVID-19 patients.
The second drug, Infliximab (CT-P13) developed by Slough based Celltrion Healthcare UK, is an anti-tumour necrosis factor (TNF) therapy that is designed to attach to a protein involved in inflammation and is currently used as a treatment other inflammatory conditions including eight autoimmune diseases including rheumatoid arthritis and irritable bowel syndrome under the trade name Remsima®.
It is hoped that by using drugs that target the most serious symptoms of the virus, the severity of the disease could be reduced leading to a reduction in the number of patients needing to be admitted to intensive care and ultimately, a reduction in virus related deaths.
Dr Ben Fisher, co-clinical investigator of the CATALYST trial from the University of Birmingham’s Institute of Inflammation and Ageing and Consultant Rheumatologist at UHB said: “There has been a tremendous effort to pull together this initiative so rapidly. Emerging evidence is demonstrating a critical role for anti-inflammatory drugs in the cytokine storm associated with severe COVID-19 infection. In the CATALYST study we hope to show with a single dose of these kinds of drugs in hospitalised patients, that we are able to delay or prevent the rapid deterioration into intensive care and requirement for invasive ventilation in this critical patient group.”
“We hope that by using a treatment that is already used to treat inflammation in other autoimmune conditions we may be able to manage inflammation associated with COVID-19 early,” said Sir Marc Feldmann, Professor of Immunology, University of Oxford. “If, when people are initially admitted to hospital, we are able to keep symptoms within manageable levels, this may reduce the number of patients who need to be admitted to intensive care”.
Dr Someit Sidhu, Chief Executive and Co-founder of Izana Bioscience, said: “We are proud to be supporting the CATALYST trial led by the highly experienced team at the University of Birmingham and University Hospitals Birmingham, Europe’s largest integrated critical care centre. We believe namilumab can play a significant role in dampening the hyper-inflammation seen in patients with severe COVID-19 infection and are committed to working with regulators and partners across the world to ensure this potential therapy can be developed for patients with COVID-19 who urgently need treatments. This is a particularly significant moment for me, supporting the global response to this pandemic through the work of the team at University Hospitals Birmingham – the hospital where I trained as a junior doctor before going on to found Izana”
Dr Dan Casey, Medical Advisor at Celltrion Healthcare UK said: “We’re eager to put our wealth of expertise and heritage in the treatment of inflammation towards tackling the COVID-19 outbreak. CT-P13 has been used for several years in the treatment of inflammatory conditions which makes it a good candidate for trialling in the treatment of COVID-19 due to its widespread availability and well-established safety profile”.
The trials exciting new adaptive trial design allows for more rapid testing of each drugs effectiveness, with up to 40 patients recruited to each arm. The effect of each drug will be measured by the amount of oxygen in the blood as well as using other severity indicators of the disease (i.e organ failure). Drugs that show reductions in the amount of oxygen needed by the patient and in other severity measures will be recommended for further testing within large ongoing national trials.