The Food and Drug Administration (FDA) has approved a phase 3 clinical trial to evaluate siltuximab (EUSA Pharma) plus standard of care in hospitalized patients with coronavirus disease 2019 (COVID-19) associated acute respiratory distress syndrome (ARDS).

The randomized, double-blind, placebo-controlled trial will compare the efficacy and safety of siltuximab, an interleukin-6 (IL-6) antagonist, to placebo, plus standard of care, in approximately 400 hospitalized patients with COVID-19 associated ARDS and elevated serum levels of IL-6. The primary end point of the study will be all-cause mortality at day 28. Secondary end points include time to 7-category ordinal scale of clinical status improvement, ventilator-free days within 28 days, organ failure-free days, intensive care unit length of stay, hospital length of stay, lung function and radiographic improvement.

Siltuximab has been investigated in several independent clinical trials for the treatment of severe COVID-19. Interim data from the SISCO (Siltuximab In Serious COVID-19) study showed that treatment with siltuximab plus standard of care was associated with a reduced 30-day mortality rate among patients with serious respiratory complications associated with COVID-19. The new phase 3 trial is being conducted to confirm the safety and efficacy of the treatment.

“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,” said Lee Morley, CEO, EUSA Pharma. “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.”

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Siltuximab is currently marketed under the trade name Sylvant and is indicated for the treatment of multicentric Castleman’s disease (MCD) in adults who are HIV negative and human herpesvirus-8 (HHV-8) negative.

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