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)
December 17, 2020HEMEL HEMPSTEAD, United Kingdom & BURLINGTON, Mass.–(BUSINESS WIRE)–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. (Read more…) medRxiv June 2020; DOI: https://doi.org/10.1101/2020.04.01.20048561.
—–
About the ‘SILVAR’ Study
SILtuximab in Viral ARDS (‘SILVAR’) is an FDA-approved, prospective, multicentre, randomised, double-blind, placebo-controlled, parallel-arm, Phase 3 clinical trial designed to compare the efficacy and safety of intravenous siltuximab plus SOC to intravenous normal saline plus SOC in selected hospitalised patients with COVID-19 previously treated with corticosteroids or another respiratory virus infection associated with ARDS. This US multicentre clinical trial will aim to enrol approximately 555 patients with serious viral ARDS and elevated serum levels of IL-6 as measured by its qualified C-reactive protein (CRP) surrogate. The primary objective is to demonstrate a significant reduction in 28-day mortality with the addition of siltuximab to SOC. Secondary objectives are to compare other measures of efficacy between both treatment arms and to evaluate the safety, tolerability, exposure, and immunogenicity of siltuximab in this patient population and treatment setting. For more information, please visit www.clinicaltrials.gov/ct2/show/NCT04616586.
About Siltuximab
Siltuximab is a monoclonal antibody that directly neutralises IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions. It is currently approved by the US Food and Drug Administration (FDA) and the European Commission (EC), as well as health regulatory authorities in several other jurisdictions worldwide, for the treatment of adult patients with Multicentric Castleman Disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. EUSA Pharma has exclusive rights to siltuximab (SYLVANT® ▼) globally. Indications and Usage of SYLVANT – See EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information for additional information.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company is headquartered in Hemel Hempstead, England (UK), and has extensive commercial operations in the United States and Europe, alongside a direct presence in selected other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and it is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information, please visit www.eusapharma.com.
About Atrium Health
Atrium Health is a nationally recognized leader in shaping health outcomes through innovative research, education and compassionate patient care. Atrium Health is an integrated, non-profit health system with more than 70,000 teammates serving patients at 42 hospitals and more than 1,500 care locations. It provides care under the Wake Forest Baptist Health name in the Winston-Salem, North Carolina, region and Navicent Health in Georgia. Atrium Health is renowned for its top-ranked pediatric, cancer and heart care, as well as organ transplants, burn treatments and specialized musculoskeletal programs. A recognized leader in experiential medical education and ground breaking research, Wake Forest School of Medicine is the academic core of the enterprise, including Wake Forest Innovations, which is advancing new medical technologies and biomedical discoveries. Atrium Health is also a leading-edge innovator in virtual care and mobile medicine, providing care close to home and in the home. Ranked among U.S. News & World Report’s Best Hospitals for cancer treatment and in eight pediatric specialties, Atrium Health has also received the American Hospital Association’s Quest for Quality Prize and was the recipient of the 2020 Centers for Medicare & Medicaid Services Health Equity Award for its efforts to reduce racial and ethnic disparities in care. With a commitment to every community it serves, Atrium Health seeks to improve health, elevate hope and advance healing – for all, providing more than $2 billion per year in free and uncompensated care and other community benefits.
Contacts
EUSA Media
Rebecca Kerr
+44 7909 703627
[email protected]
GL-NPS-2000043. December 2020
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)
December 17, 2020HEMEL HEMPSTEAD, United Kingdom & BURLINGTON, Mass.–(BUSINESS WIRE)–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. (Read more…) medRxiv June 2020; DOI: https://doi.org/10.1101/2020.04.01.20048561.
—–
About the ‘SILVAR’ Study
SILtuximab in Viral ARDS (‘SILVAR’) is an FDA-approved, prospective, multicentre, randomised, double-blind, placebo-controlled, parallel-arm, Phase 3 clinical trial designed to compare the efficacy and safety of intravenous siltuximab plus SOC to intravenous normal saline plus SOC in selected hospitalised patients with COVID-19 previously treated with corticosteroids or another respiratory virus infection associated with ARDS. This US multicentre clinical trial will aim to enrol approximately 555 patients with serious viral ARDS and elevated serum levels of IL-6 as measured by its qualified C-reactive protein (CRP) surrogate. The primary objective is to demonstrate a significant reduction in 28-day mortality with the addition of siltuximab to SOC. Secondary objectives are to compare other measures of efficacy between both treatment arms and to evaluate the safety, tolerability, exposure, and immunogenicity of siltuximab in this patient population and treatment setting. For more information, please visit www.clinicaltrials.gov/ct2/show/NCT04616586.
About Siltuximab
Siltuximab is a monoclonal antibody that directly neutralises IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions. It is currently approved by the US Food and Drug Administration (FDA) and the European Commission (EC), as well as health regulatory authorities in several other jurisdictions worldwide, for the treatment of adult patients with Multicentric Castleman Disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. EUSA Pharma has exclusive rights to siltuximab (SYLVANT® ▼) globally. Indications and Usage of SYLVANT – See EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information for additional information.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company is headquartered in Hemel Hempstead, England (UK), and has extensive commercial operations in the United States and Europe, alongside a direct presence in selected other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and it is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information, please visit www.eusapharma.com.
About Atrium Health
Atrium Health is a nationally recognized leader in shaping health outcomes through innovative research, education and compassionate patient care. Atrium Health is an integrated, non-profit health system with more than 70,000 teammates serving patients at 42 hospitals and more than 1,500 care locations. It provides care under the Wake Forest Baptist Health name in the Winston-Salem, North Carolina, region and Navicent Health in Georgia. Atrium Health is renowned for its top-ranked pediatric, cancer and heart care, as well as organ transplants, burn treatments and specialized musculoskeletal programs. A recognized leader in experiential medical education and ground breaking research, Wake Forest School of Medicine is the academic core of the enterprise, including Wake Forest Innovations, which is advancing new medical technologies and biomedical discoveries. Atrium Health is also a leading-edge innovator in virtual care and mobile medicine, providing care close to home and in the home. Ranked among U.S. News & World Report’s Best Hospitals for cancer treatment and in eight pediatric specialties, Atrium Health has also received the American Hospital Association’s Quest for Quality Prize and was the recipient of the 2020 Centers for Medicare & Medicaid Services Health Equity Award for its efforts to reduce racial and ethnic disparities in care. With a commitment to every community it serves, Atrium Health seeks to improve health, elevate hope and advance healing – for all, providing more than $2 billion per year in free and uncompensated care and other community benefits.
Contacts
EUSA Media
Rebecca Kerr
+44 7909 703627
[email protected]
GL-NPS-2000043. December 2020
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)
December 17, 2020HEMEL HEMPSTEAD, United Kingdom & BURLINGTON, Mass.–(BUSINESS WIRE)–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. (Read more…) medRxiv June 2020; DOI: https://doi.org/10.1101/2020.04.01.20048561.
—–
About the ‘SILVAR’ Study
SILtuximab in Viral ARDS (‘SILVAR’) is an FDA-approved, prospective, multicentre, randomised, double-blind, placebo-controlled, parallel-arm, Phase 3 clinical trial designed to compare the efficacy and safety of intravenous siltuximab plus SOC to intravenous normal saline plus SOC in selected hospitalised patients with COVID-19 previously treated with corticosteroids or another respiratory virus infection associated with ARDS. This US multicentre clinical trial will aim to enrol approximately 555 patients with serious viral ARDS and elevated serum levels of IL-6 as measured by its qualified C-reactive protein (CRP) surrogate. The primary objective is to demonstrate a significant reduction in 28-day mortality with the addition of siltuximab to SOC. Secondary objectives are to compare other measures of efficacy between both treatment arms and to evaluate the safety, tolerability, exposure, and immunogenicity of siltuximab in this patient population and treatment setting. For more information, please visit www.clinicaltrials.gov/ct2/show/NCT04616586.
About Siltuximab
Siltuximab is a monoclonal antibody that directly neutralises IL-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions. It is currently approved by the US Food and Drug Administration (FDA) and the European Commission (EC), as well as health regulatory authorities in several other jurisdictions worldwide, for the treatment of adult patients with Multicentric Castleman Disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. EUSA Pharma has exclusive rights to siltuximab (SYLVANT® ▼) globally. Indications and Usage of SYLVANT – See EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information for additional information.
About EUSA Pharma
Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company is headquartered in Hemel Hempstead, England (UK), and has extensive commercial operations in the United States and Europe, alongside a direct presence in selected other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and it is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information, please visit www.eusapharma.com.
About Atrium Health
Atrium Health is a nationally recognized leader in shaping health outcomes through innovative research, education and compassionate patient care. Atrium Health is an integrated, non-profit health system with more than 70,000 teammates serving patients at 42 hospitals and more than 1,500 care locations. It provides care under the Wake Forest Baptist Health name in the Winston-Salem, North Carolina, region and Navicent Health in Georgia. Atrium Health is renowned for its top-ranked pediatric, cancer and heart care, as well as organ transplants, burn treatments and specialized musculoskeletal programs. A recognized leader in experiential medical education and ground breaking research, Wake Forest School of Medicine is the academic core of the enterprise, including Wake Forest Innovations, which is advancing new medical technologies and biomedical discoveries. Atrium Health is also a leading-edge innovator in virtual care and mobile medicine, providing care close to home and in the home. Ranked among U.S. News & World Report’s Best Hospitals for cancer treatment and in eight pediatric specialties, Atrium Health has also received the American Hospital Association’s Quest for Quality Prize and was the recipient of the 2020 Centers for Medicare & Medicaid Services Health Equity Award for its efforts to reduce racial and ethnic disparities in care. With a commitment to every community it serves, Atrium Health seeks to improve health, elevate hope and advance healing – for all, providing more than $2 billion per year in free and uncompensated care and other community benefits.
Contacts
EUSA Media
Rebecca Kerr
+44 7909 703627
[email protected]
GL-NPS-2000043. December 2020