19 March 2020 - - Biopharmaceutical company EUSA Pharma has launched the Papa Giovanni XXIII Hospital sponsored study of siltuximab, an interleukin -6 targeted monoclonal antibody, for the treatment of patients with COVID-19 who have developed serious respiratory complications (Siltuximab In Serious COVID-19; SISCO Study), the company said.

Ergomed plc (LSE: ERGO), a company focused on providing specialized services to the pharmaceutical industry, is providing clinical research services for the study.

Sponsored by the Papa Giovanni XXIII Hospital, the SISCO Study is an observational case-control trial of siltuximab, a chimeric monoclonal antibody targeting human interleukin -6, for the treatment of patients infected with COVID-19 who develop serious respiratory complications.

The study represents the data collection and analysis of a series of patients treated under an ongoing emergency compassionate use protocol.

The study will investigate two cohorts retrospectively, hospitalised patients prior to admission to an intensive care unit or patients already requiring intensive care, and will compare to matched controls.

Primary endpoints are reduction in the need of invasive ventilation, time spent in ICU or 30-day mortality.

Emerging evidence suggests that exacerbated production of the inflammatory cytokine IL-6 is associated with the severity of COVID-19 related pulmonary pathology associated with Acute Respiratory Distress Syndrome.

Therefore, direct targeting of this cytokine may improve clinical outcomes in these critically ill patients.

This study will provide important data to inform future clinical studies, discussions on which are ongoing, to further investigate the efficacy of siltuximab in patients with COVID-19 who develop serious respiratory complications. Initial data are expected in late March 2020.

Siltuximab is a monoclonal antibody that blocks the action of interleukin -6, a multifunctional cytokine detected at elevated levels in multiple inflammatory conditions.

It is approved by the US Food and Drug Administration and the European Medicines Agency under the brand name of SYLVANT for the treatment of patients with multicentric Castleman disease who are human immunodeficiency virus negative and human herpesvirus-8 (HHV-8) negative (idiopathic MCD; iMCD).

iMCD is a rare, life-threatening and debilitating lymphoproliferative disorder, which causes abnormal overgrowth of immune cells and shares many symptomatic and histological features with lymphoma.

EUSA Pharma has exclusive rights to Sylvant globally. EUSA Pharma has granted BeiGene, Ltd., exclusive development and commercialization rights to Sylvant in Greater China.

Papa Giovanni XXIII Hospital is one of the biggest hospitals in Lombardy, covering 320 thousand square meters in total and comprising more than 900 beds.