HEMEL HEMPSTEAD, United Kingdom & BURLINGTON, Massachusetts – 2 JULY 2020 –
EUSA Pharma, a global biopharmaceutical company focused on oncology and rare disease, today announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase 3 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).
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.
Lee Morley, Chief Executive Officer, EUSA Pharma, said: “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.”
To date, several independent clinical trials have begun globally to explore the safety and efficacy of siltuximab for the treatment of severe COVID-19 patients. Final results from the Papa Giovanni XXIII Hospital sponsored SISCO1 (Siltuximab In Serious COVID-19) Study, an observational cohort control trial investigating siltuximab plus standard of care in COVID-19 patients with serious respiratory complications, are available via pre-print summary here.2 However, the newly approved confirmatory clinical trial is vital because these findings require validation in a well-controlled randomized study and there is limited published data on the safety and efficacy of siltuximab in COVID-19. Siltuximab is also not yet FDA-approved for complications associated with COVID-19.
About the New Clinical Trial
EUSA Pharma has received FDA approval to proceed with a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated ARDS, compared to placebo plus standard of care. The multicentre trial will aim to enrol approximately 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.
Siltuximab is a monoclonal antibody that directly neutralizes interleukin (IL)-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions, of which potentially there may be a role in patients with COVID-19. It is currently approved by the FDA and the European Medicines Agency (EMA) as well as regulatory bodies in a number of other jurisdictions worldwide, for the treatment of patients with multicentric Castleman disease (MCD). EUSA Pharma has exclusive rights to SYLVANT® (Siltuximab) globally. Indications and Usage of SYLVANT – See EMA Summary of Product Characteristics (SmPC) for Additional Details.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has extensive commercial operations in the United States and Europe, alongside a direct presence in select other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information please visit: www.eusapharma.com.
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An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications (SISCO) [NCT04322188]: https://www.clinicaltrials.gov/ct2/show/NCT04322188
IL-6 Signalling Pathway Inactivation With Siltuximab in Patients With COVID-19 Respiratory Failure: an Observational Cohort Study. Gritti et al; medRxiv 2020.04.01.20048561; doi: https://doi.org/10.1101/2020.04.01.20048561