EUSA Pharma bags US approval for COVID-19 trial

US regulators have issued a green light for a Phase III clinical trial testing EUSA Pharma's for patients seriously ill 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.

The randomised, double-blind, placebo-controlled trial will evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalised patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).

The multicentre trial will aim to enrol around 400 patients with viral ARDS and elevated serum levels of IL-6. The primary objective is to evaluate all-cause mortality at 28 days with the addition of siltuximab to standard of care, compared to placebo plus standard of care.

Secondary objectives 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.

“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,” said Lee Morley, EUSA Pharma's chief executive.

Several independent clinical trials have begun globally to explore the safety and efficacy of siltuximab for the treatment of severe COVID-19 patients. However, the newly approved confirmatory clinical trial is vital because these findings require validation in a well-controlled randomised study and there is limited published data on the safety and efficacy of siltuximab in COVID-19, the firm noted.