Celltrion Healthcare is partnering with the University of Oxford and University Hospitals Birmingham to study the use of CT-P13 (biosimilar infliximab) to accelerate COVID-19 recovery.
CT-P13 is being trialled to understand if it could accelerate the recovery of people with COVID-19 symptoms. Severe COVID-19 is associated with a major immune inflammatory response and therefore therapies that have the potential to target this could be used as a treatment for COVID-19. Infliximab is an anti-TNF therapy that is designed to attach to TNF, a protein important in inflammation, and is currently used as a treatment for other inflammatory conditions.
Although there are many potential drug candidates for reducing inflammation in COVID-19, only a few, such as the anti-TNF antibodies infliximab or adalimumab, would be suitable to address the current urgent need to treat people with COVID-19. This is because these treatments already have significant real-world use, are widely available and in large scale production, and have a well-established safety profile.
“Using a treatment which is effective by blocking TNF in more than 10 inflammatory diseases to treat inflammation associated with COVID-19, in which levels of TNF are also high, makes a lot of sense,” said Sir Marc Feldmann, Professor of Immunology, University of Oxford, one of the inventors of infliximab. “If treated with infliximab upon admission to hospital, the number of patients who may need to be admitted to intensive care may be reduced.”
The new treatment arm of the trial will assess whether treatment with CT-P13 is associated with improved oxygen saturation levels when compared to the current standard of care amongst people who have been hospitalised with confirmed COVID-19 and have been identified as at risk of deterioration. Oxygen saturation measures provide an indication for how well the lungs are functioning.
“We’re eager to put our wealth of expertise and heritage in the treatment of inflammation towards tackling the COVID-19 outbreak,” said Dr Dan Casey, Medical Advisor, Celltrion Healthcare UK. “CT-P13 has been used for several years in the treatment of multiple 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”.
CT-P13 (infliximab biosimilar) is currently indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease under the trade name Remsima®. CT-P13 is not approved for the treatment of COVID-19.
The trial will take place across 12 sites in the Midlands with the first participant due to receive treatment in June. If the CATALYST trial were to indicate a potential benefit from treatment with CT-P13 it would then be assessed in larger scale trials in one of the UK national platform trials, RECOVERY or REMAP-CAP.