FDA ok for Phase III trial of siltuximab for COVID-19

The US Food and Drug Administration has approved a randomized, double-blind, placebo-controlled Phase III clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated acute respiratory distress syndrome (ARDS), privately-held UK drugmaker EUSA Pharma announced today.

Siltuximab is a monoclonal antibody that directly neutralizes 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.

EUSA Pharma chief executive Lee Morley commented: “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 recognized as a key driver of this severe condition. Treatment approaches neutralizing 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 recognizing the importance of this clinical trial and the quick approval we received. Our plan now is to initiate the study as quickly as possible with the hope of seeing improved clinical outcomes in these critically ill patients.”