Sponsored study begins in Italy for Covid-19

A sponsored study of the monoclonal antibody siltuximab is being conducted in Italy to see if the therapy can help treat Covid-19 patients who have developed serious respiratory complications.

Global biopharmaceutical company EUSA Pharma will supply the Papa Giovanni XXIII Hospital in Bergamo, Italy with siltuximab, which will be used on a compassionate basis for patients with Covid-19.

Siltuximab is an interleukin (IL)-6 targeted monoclonal antibody that is currently used in treating Multicentric Castleman Disease (MCD). The treatment targets the production of the inflammatory cytokine IL-6, which has been associated with the severity of Covid-19 related Acute Respiratory Distress Syndrome (ARDS). The study hopes to find out whether the direct targeting of this cytokine may improve clinical outcomes in these critically ill patients.

Professor Alessandro Rambaldi, Papa Giovanni XXIII Hospital, Bergamo, Italy, study sponsor-investigator and director of the Hematology Unit and Department of Oncology and Hematology, said: “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 SISCO 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.”

Lee Morley, chief executive officer, EUSA Pharma, said: “We are delighted to support this study to investigate the potential for siltuximab to help patients severely ill as a result of Covid-19. 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. 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.”