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The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.
United Kingdom-based EUSA Pharma, a biopharmaceutical company focused on oncology and rare disease, has partnered with Bergamo, Italy-based Papa Giovanni XXIII Hospital, one of the largest hospitals in the Lombardy region of Italy, to study siltuximab, an interleukin (IL)-6 targeted monoclonal antibody (mAb) as a potential treatment for the novel coronavirus (COVID-19). The company announced on March 18, 2020 that they have initiated a sponsored study of siltuximab for treating patients with COVID-19 who have developed serious respiratory complications.
Ergomed, a UK-based contract research organization (CRO), is providing clinical research services for the study. The study, labeled as the Siltuximab In Serious COVID-19 (SISCO) 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–hospitalized patients prior to admission to an intensive care unit (ICU) and 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 (ARDS). Direct targeting of this cytokine may therefore improve clinical outcomes in these critically ill patients, according to EUSA Pharma.
The study will also 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.
“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,” said Professor Alessandro Rambaldi, MD, PhD, study sponsor-investigator and director of the Hematology Unit and Department of Oncology and Hematology, at Papa Giovanni XXIII Hospital, in a press release issued by EUSA Pharma.
“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 [a]cute [r]espiratory [d]istress [s]yndrome 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 [w]orldwide [r]egulatory [a]uthorities, and other research bodies to fully understand the potential of siltuximab at this critical time in the global pandemic,” added Lee Morley, CEO, EUSA Pharma, in the press release.
Siltuximab is approved by FDA and the European Medicines Agency under the brand name of Sylvant for treating patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative, or idiopathic MCD. Sylvant was a product of Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
In January 2019, EUSA Pharma acquired the exclusive worldwide rights to Sylvant from Janssen in a $115-million deal. EUSA Pharma has since granted BeiGene, a China-based commercial-stage research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics, exclusive development and commercialization rights to Sylvant in Greater China.
Source: EUSA Pharma