The US Food and Drug Administration (FDA) has approved EUSA Pharma’s Phase III trial protocol to study siltuximab plus standard of care in Covid-19 patients hospitalised with Acute Respiratory Distress Syndrome (ARDS).
The drug is a monoclonal antibody that directly neutralises interleukin-6 (IL-6) and therefore is believed to combat the deadly cytokine known to be caused by Covid-19 associated ARDS.
EUSA Pharma CEO Lee Morley explained: “Since the start of the pandemic, a growing body of evidence has been published highlighting that Covid19 associated ARDS may exhibit features of systemic hyper-inflammation, 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 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.”