The US Food & Drug Administration (FDA) has approved a randomised, double-blind, placebo-controlled phase III clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab.
It will also evaluate the standard of care in hospitalised patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).
Siltuximab is a monoclonal antibody that directly neutralises interleukin (IL)-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions, including COVID-19. It specifically binds to IL-6, thereby inactivating IL-6 induced signalling.
Lee Morley, Chief Executive Officer, EUSA Pharma, said:“Since the start of the pandemic, a growing body of evidence has been published highlighting that COVID-19 associated ARDS may exhibit features of systemic hyperinflammation, resulting from excessive cytokine production – the so-called ‘cytokine storm’ – with IL-6 recognised as a key driver of this severe condition. Treatment approaches neutralising IL-6 could therefore play a key role in mitigating further detrimental inflammation and progression to respiratory failure, which can be fatal. We thank the FDA for recognising the importance of this clinical trial and the quick approval we received. Our plan now is to initiate the study asquickly as possible with the hope of seeing improved clinical outcomes in these critically ill patients.”
To date, several independent clinical trials have begun globally to explore the safety and efficacy of siltuximab for the treatment of severe COVID-19 patients. Final results from the Papa Giovanni XXIII Hospital sponsored SISCO(SiltuximabIn Serious COVID-19) Study, an observational cohort control trial investigating siltuximab plus standard of care in COVID-19 patients with serious respiratory complications, are available via pre-print summary here.However, the newly approved confirmatory clinical trial is vital because these findings require validation in a well-controlled randomized study and there is limited published data on the safety and efficacy of siltuximab in COVID-19. Siltuximab is also not yet FDA-approved for complications associated with COVID-19.