EUSA Pharma Announces First Patient Enrolled in a Randomised Phase 3 Clinical Trial Investigating Siltuximab in Hospitalised Patients with COVID-19- or Another Respiratory Virus Infection-Associated Acute Respiratory Distress Syndrome (ARDS)

EUSA Pharma Announces First Patient Enrolled in a Randomised Phase 3 Clinical Trial Investigating Siltuximab in Hospitalised Patients with COVID-19- or Another Respiratory Virus Infection-Associated Acute Respiratory Distress Syndrome (ARDS)

HEMEL HEMPSTEAD, United Kingdom and BURLINGTON, Massachusetts – 17 December 2020

EUSA Pharma (UK) Limited (“EUSA Pharma”), a global biopharmaceutical company, announced today that the first patient has been enrolled in the SILtuximab in Viral ARDS (‘SILVAR’) study at the Sparrow Hospital in Lansing, Michigan. The ‘SILVAR’ study is a prospective, multicentre, randomised, double-blind, placebo-controlled, parallel-arm, Phase 3 study designed to confirm the encouraging results of the observational, single-centre, control-cohort in the Siltuximab In Serious COVID-19 (‘SISCO’) study.¹ The results from 30 patients treated with siltuximab in the ‘SISCO’ study compared with 30 matched controls, showed that treatment with siltuximab led to a 54% reduction in risk of 30-day all-cause mortality.²

This pivotal study will evaluate the efficacy and safety of standard of care (SOC) with or without intravenous siltuximab in selected hospitalised patients with COVID-19 previously treated with corticosteroids or another respiratory virus infection. Unlike previous studies of agents targeting the interleukin-6 (IL-6) signalling pathway, the ‘SILVAR’ study has been rationally designed to only enrol those hospitalised patients suffering from serious viral acute respiratory distress syndrome (ARDS) in a hyperinflammatory state that will most likely benefit from the addition of an anti-IL-6 immunomodulator such as siltuximab.

Lee Morley, Chief Executive Officer, EUSA Pharma, said, “We are delighted to have enrolled the first patient in the ‘SILVAR’ study of siltuximab, a monoclonal antibody that binds to and neutralises IL-6, an important mediator of the immune response to infection. This clinical trial represents an important step in finding a solution for hospitalised patients with serious respiratory complications due to an over reactive immune response to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) infection that is not fully responsive to corticosteroid therapy, as well as those with any other respiratory virus infection associated with serious ARDS.

Zainab Shahid, MD, FACP, infectious disease physician with Atrium Health and Lead Principal Investigator on the ‘SILVAR’ study, said, “Patients with serious viral ARDS have some of the highest mortality rates despite recent improvements in intensive care. The ‘SILVAR’ study is a very important step to potentially confirm the encouraging results of the Italian observational cohort-control ‘SISCO’ study in a prospective, randomised, controlled fashion.”

References

1. Siltuximab In Serious COVID-19 (SISCO) study (NCT04322188); https://www.clinicaltrials.gov/ct2/show/NCT04322188  

2. Gritti G, et al. IL-6 signalling pathway inactivation with siltuximab in patients with COVID-19 respiratory failure: an observational cohort study. medRxiv June 2020; DOI: https://doi.org/10.1101/2020.04.01.20048561.