EUSA Pharma’s Vaccine Gets Approval for COVID-19 Trial

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Regulators in the United States have given approval for a Phase III clinical trial of EUSA Pharma’s vaccine for patients suffering from COVID-19 related Acute Respiratory Distress Syndrome (ARDS).

A monoclonal antibody, Siltuximab directly neutralizes interleukin (IL)-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions, including COVID-19. It has the propensity to specifically bind to IL-6, thereby inactivating IL-6 induced signaling.

The double-blind, randomized and placebo-controlled trial is aimed at evaluating the safety and efficacy of intravenous Siltuximab side by side standard care in hospitalised patients with COVID-19 related Acute Respiratory Distress Syndrome (ARDS).

The multi-centre trial aims 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.

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Secondary objectives include the following: 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, lung function and radiographic improvement.

According to EUSA Pharma’s Chief Executive Lee Morley : “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 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”.

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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 clinical trial is very important owing to the fact that these findings require confirmation in a well-controlled and randomised study, though there is limited published data on the safety and efficacy of Siltuximab in COVID-19, EUSA Pharma observed.

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