Celltrion Drug Is Tested in COVID-19 CATALYST Trial

Celltrion Healthcare’s infliximab biosimilar (Remsima, CT-P13) has been chosen for testing in the CATALYST study, which will assess the effectiveness of potential therapeutics for the treatment of patients hospitalized with coronavirus disease 2019 (COVID-19).

“CT-P13 has been used for several years in the treatment of inflammatory conditions, which makes it a good [clinical trial] candidate for…the treatment of COVID-19 due to its widespread availability and well-established safety profile,” said Dan Casey, MD, medical advisor at Celltrion Healthcare UK, in a statement.

CT-P13 has been marketed in the European Union since February 2015 and is used for the treatment of inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, plaque psoriasis, and ulcerative colitis.

“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….This may reduce the number of patients who need to be admitted to intensive care,” said Sir Marc Feldmann FRS, professor of immunology at the University of Oxford.

Cytokine Release Syndrome and Remsima

The biosimilar is hoped to prevent cytokine release syndrome (CRS), a powerful immune response that can lead to inflammation-induced lung injuries or complications such as pneumonitis, acute respiratory distress syndrome, respiratory failure, shock, organ failure, and potentially death.

CRS is commonly associated with immune system—related diseases and therapy, including chimeric antigen receptor T-cell therapy, organ transplantation sepsis, and viral infections.

“Cytokine storms” occur in a subgroup of patients with COVID-19 for unknown reasons and are characterized by elevated levels of cytokines, likely produced by inflammatory macrophages that secrete interleukin (IL)-6, IL-10, and tumor necrosis factor (TNF)-α. CT-P13 inhibits TNF-α.

The CATALYST trial is a collaboration between the University of Birmingham and the University of Oxford and will test a series of new drugs, in addition to CT-P13, with the potential for COVID-19 treatment, such as namilumab (IZN-101), which is in late-stage clinical trials for the treatment of rheumatoid arthritis and ankylosing spondylitis.

“We hope to show with a single dose of these kinds of drugs in hospitalized patients that we are able to delay or prevent the rapid deterioration into intensive care and [the] requirement for invasive ventilation in this critical patient group,” said Ben Fisher, MD, co-clinical investigator of the CATALYST trial from the University of Birmingham’s Institute of Inflammation and Aging and consultant rheumatologist at University Hospitals Birmingham National Health Service Foundation Trust.

The trial features a new adaptive design that will allow for faster testing of each drug’s effectiveness. Each arm of the study will have up to 40 recruited subjects, and the effectiveness of each drug will be measured by the amount of oxygen in the blood and through the use of other severity indicators of COVID-19, such as organ failure.

Drugs showing a reduction in the amount of oxygen needed by the patient and other severity measures will be recommended to be tested in larger ongoing UK trials.

Celltrion, based in Incheon, Republic of Korea, has ambitious plans in the biosimilar space. It aims to launch up to 10 new biosimilars over the coming decade and create an aggressive European sales network. Success with Remsima as a COVID-19 treatment option could further accelerate the company's growth and prospects.

Reference

Torres T, Puig L. Managing cutaneous immune‐mediated diseases during the COVID‐19 pandemic. J Clin Dermatol. Published online April 10, 2020. doi:10.1007/s40257-020-00514-2