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EUSA Pharma and Ergomed partner to investigate IL-6 targeting in COVID-19 patients with serious respiratory complications

Published on 31/03/20 at 10:10am

Oncology and rare disease firm EUSA Pharma is aiding in the global fight against the novel coronavirus with the launch of a study investigating the efficacy of siltuximab, an interleukin (IL)-6 targeted monoclonal antibody, in the treatment of patients with COVID-19 who have developed serious respiratory complications.

The study, sponsored by the Papa Giovanni XXIII Hospital in Bergamo, Italy, will examine patients currently treated under an ongoing emergency compassionate use protocol, split into two cohorts retrospectively: hospitalised patients prior to admission to an intensive care unit (ICU), and patients already requiring intensive care.

The main goals of the study are reduction in the need of invasive ventilation, time spent in ICU or 30-day mortality. Ergomed is providing clinical research services for the study.

Our evolving understanding of COVID-19 suggests the severity of pulmonary pathology associated with Acute Respiratory Distress Syndrome (ARDS) in patients infected with the novel coronavirus is linked to increased production of the inflammatory cytokine IL-6. It is theorised that direct targeting of this cytokine may improve clinical outcomes in these critically ill patient groups.

“Following the release of initial data from China suggesting a role of IL-6 in the development of Acute Respiratory Distress Syndrome as a result of COVID-19, EUSA Pharma was pleased to assist Papa Giovanni XXIII Hospital with the supply of siltuximab under compassionate use and to support the collection, analysis and publication of initial outcome data from this series of patients,” commented Lee Morley, Chief Executive Officer at EUSA Pharma. “We look forward to working further with the Hospital as well as Italian and Worldwide Regulatory Authorities, and other research bodies to fully understand the potential of siltuximab at this critical time in the global pandemic.”

Professor Alessandro Rambaldi, of Papa Giovanni XXIII Hospital, Study Sponsor-Investigator and Director of the Hematology Unit and Department of Oncology and Hematology, also remarked: “The team at Papa Giovanni XXIII Hospital are thankful to EUSA Pharma for the supply of siltuximab for compassionate use in patients with serious complications of COVID-19 and the opportunity to generate data to understand the potential for IL-6 blockade in these patients. The study will allow us to generate credible data as evidence to guide future treatment and research decisions and we look forward to publication of these data as quickly as possible. The Hospital is in a very difficult emergency situation and rapid collection and analysis of data by way of a case-control study will provide much needed information to help address this critical situation and appropriately guide the use of medicines in an off-label situation.”

Matt Fellows

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