Business Wire

EUSA Pharma Announces FDA Approval of Phase 3 Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Share

EUSA Pharma, a global biopharmaceutical company focused on oncology and rare disease, today announced that the U.S. Food & Drug Administration (FDA) has approved a randomized, double-blind, placebo-controlled Phase 3 clinical trial protocol to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS).

Siltuximab is a monoclonal antibody that directly neutralizes interleukin (IL)-6, an inflammatory cytokine detected at elevated levels in multiple inflammatory conditions, including COVID-19. It specifically binds to IL-6, thereby inactivating IL-6 induced signalling.

Lee Morley, Chief Executive Officer, EUSA Pharma, said: “Since the start of the pandemic, a growing body of evidence has been published highlighting that COVID-19 associated ARDS may exhibit features of systemic hyperinflammation, resulting from excessive cytokine production – the so-called ‘cytokine storm’ – with IL-6 recognized as a key driver of this severe condition. Treatment approaches neutralizing IL-6 could therefore play a key role in mitigating further detrimental inflammation and progression to respiratory failure, which can be fatal. We thank the FDA for recognizing the importance of this clinical trial and the quick approval we received. Our plan now is to initiate the study as quickly as possible with the hope of seeing improved clinical outcomes in these critically ill patients.”

To date, several independent clinical trials have begun globally to explore the safety and efficacy of siltuximab for the treatment of severe COVID-19 patients. Final results from the Papa Giovanni XXIII Hospital sponsored SISCO 1 (Siltuximab In Serious COVID-19) Study, an observational cohort control trial investigating siltuximab plus standard of care in COVID-19 patients with serious respiratory complications, are available via pre-print summary here.2 However, the newly approved confirmatory clinical trial is vital because these findings require validation in a well-controlled randomized study and there is limited published data on the safety and efficacy of siltuximab in COVID-19. Siltuximab is also not yet FDA-approved for complications associated with COVID-19.

About the New Clinical Trial

EUSA Pharma has received FDA approval to proceed with a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the safety and efficacy of intravenous siltuximab plus standard of care in hospitalized patients with COVID-19 associated ARDS, compared to placebo plus standard of care. The multicentre trial will aim to enrol approximately 400 patients with viral ARDS and elevated serum levels of IL-6. The primary objective is to evaluate all-cause mortality at 28 days with the addition of siltuximab to standard of care, compared to placebo plus standard of care. Secondary objectives include: time to 7-category ordinal scale of clinical status improvement, ventilator-free days within 28 days, organ failure-free days, intensive care unit length of stay, hospital length of stay, lung function and radiographic improvement.

About SYLVANT® (siltuximab)

SYLVANT is an IL-6 targeted monoclonal antibody approved by the FDA and the European Medicines Agency (EMA) as well as regulatory bodies in a number of other jurisdictions worldwide, for the treatment of patients with multicentric Castleman disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative (also known as idiopathic MCD). EUSA Pharma has exclusive rights to SYLVANT globally. EUSA Pharma has granted BeiGene, Ltd., exclusive development and commercialization rights to SYLVANT in Greater China.

SYLVANT is not licensed for the treatment of COVID-19.

Indications and Usage of SYLVANT – See Full Prescribing Information for Additional Details.

SYLVANT is indicated for the treatment of patients with MCD who are HIV negative and HHV-8 negative.

Limitations of Use: SYLVANT was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.

Contraindications: Severe hypersensitivity reaction to siltuximab or any of the excipients in SYLVANT.

Dosage and Administration

Administer SYLVANT 11 mg/kg over 1 hour as an intravenous infusion every 3 weeks until failure.

Perform hematology laboratory tests prior to each dose of SYLVANT therapy for the first 12 months and every 3 dosing cycles thereafter. If treatment criteria outlined in the Prescribing Information are not met, consider delaying treatment with SYLVANT. Do not reduce dose.

Do not administer SYLVANT to patients with severe infections until the infection resolves.

Discontinue SYLVANT in patients with severe infusion related reactions, anaphylaxis, severe allergic reactions, or cytokine release syndromes. Do not reinstitute treatment.

About EUSA Pharma

Founded in March 2015, EUSA Pharma is a world-class biopharmaceutical company focused on oncology and rare disease. The company has extensive commercial operations in the United States and Europe, alongside a direct presence in select other markets across the globe. EUSA Pharma is led by an experienced management team with a strong record of building successful pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. For more information please visit: www.eusapharma.com.

References

1 An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications (SISCO) [NCT04322188]: https://www.clinicaltrials.gov/ct2/show/NCT04322188

2 IL-6 Signalling Pathway Inactivation With Siltuximab in Patients With COVID-19 Respiratory Failure: an Observational Cohort Study. Gritti et al; medRxiv 2020.04.01.20048561; doi: https://doi.org/10.1101/2020.04.01.20048561

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Lee Morley
Chief Executive
EUSA Pharma
Email: covid.press@eusapharma.com

Barney Mayles
Associate Director
OPEN Health
Email: barneymayles@openhealthgroup.com
Mobile: +44 (0)7936 768568

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Kyowa Kirin Provides Update on Application for Marketing Authorisation of Istradefylline in Europe for the Treatment of ‘OFF’ Episodes in People Living with Parkinson’s23.7.2021 17:05:00 EEST | Press release

Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Kyowa Kirin International remain committed to istradefylline and people living with Parkinson’s and are currently reviewing the options available, which may include re-examination. “We are disappointed by the CHMP opinion. However, we remain confident in the benefit-risk profile of istradefylline and are committed to making a difference to the lives of people living with Parkinson’s, an area which has had few innovative therapies for decades,” said Abdul Mullick, President of Kyowa Kirin International. “There are currently few new treatment options available to manage end-of-dose motor fluctuations in Parkinson

ForumPay Teams Up with Bambora to Conquer the Crypto-to-Fiat Payments Market23.7.2021 16:16:00 EEST | Press release

ForumPay, an international cryptocurrency-to-fiat payment service provider, has established a partnership with the global payments provider Bambora, a Worldline brand, to bring seamless crypto payment solutions to merchants and online shoppers. The partnership will cater to a large global audience and offer expanded payment options for both shoppers and merchants. ForumPay continues its march to dominate the growing crypto payments ecosystem for merchants around the world. “ForumPay provides merchants with a seamless, secure and instant processing solution to accept payments from the more than 54 million active crypto wallet users around the world. By providing a payments service for processing crypto into fiat that functions as naturally as card payments, ForumPay enables merchants with a familiar feeling payments alternative that also gives them a competitive advantage by tapping into the fastest growing consumer base on the planet.” says Joshua Tate, CEO of ForumPay. “We are very ex

Wipro Recognized as 2021 Microsoft Modernizing Applications Partner of the Year23.7.2021 15:54:00 EEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has won the 2021 Microsoft Partner of the Year Award in the Modernizing Applications category. In addition, Wipro was also named as a category finalist in the 2021 AI Partner of the Year category, solidifying its reputation as an innovator in multiple sectors. This recognition highlights Wipro’s deep expertise and ability to go above and beyond for its customers, powered by an established partnership with Microsoft. Even when working with complex customer environments, spanning across hundreds of servers with different applications of different versions, Wipro was able to help customers meet their business needs and leverage the power of public cloud in an efficient way. “Global enterprises have embraced modernization at an unprecedented scale and pace, and the demands of the past year show no sign of easing. We are honor

Merck Announces Appointment of Head of China & International for Healthcare23.7.2021 14:45:00 EEST | Press release

Merck, a leading science and technology company, today announced that Hong Chow will join its Healthcare business sector as Head of China & International on October 1. In this role at Merck, Chow will lead China, Japan as well the regions Europe, Latin America, Asia-Pacific and Middle East, Africa and Russia, the franchise of Cardiovascular Metabolism & Endocrinology (CM&E), and the Global Business Innovation team. Chow will report to Peter Guenter, Member of the Executive Board of Merck and CEO Healthcare. She will serve as a member of the Healthcare Executive Committee, and be based in Shanghai, China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210723005186/en/ Merck Announces Appointment of Head of China & International for Healthcare (Photo: Business Wire) “Hong’s international experience and strong track record of bringing innovative medicines to patients in need across both developed and emerging markets, most nota

H.I.G. WhiteHorse Refinances Grupo Recoletas23.7.2021 14:03:00 EEST | Press release

H.I.G. WhiteHorse, a credit affiliate of global investment firm H.I.G. Capital ("H.I.G.") is pleased to announce that it has arranged a refinancing package for Grupo Hospitalario Recoletas (“Recoletas”), which includes a significant growth capital component. Recoletas is a family-owned Spanish private hospital operator headquartered in Valladolid, Spain, with a leading position in the Castilla y Leon Spanish inland region. It operates 8 hospitals with c. 540 beds and 13 medical centres across 7 regions. H.I.G. WhiteHorse has committed €110 million in unitranche loans to refinance the borrower's existing indebtedness and provide additional capital to finance growth, supporting the Company’s expansion. Recoletas is currently developing ambitious projects to expand its healthcare services provided through hospitals and medical centers, as well as diagnostic imaging centers and radiotherapy units. Amando J. Rodríguez, President and CEO of Grupo Hospitalario Recoletas, said: “We are very ha

Schlumberger Announces Second-Quarter 2021 Results23.7.2021 13:50:00 EEST | Press release

Schlumberger Limited (NYSE: SLB) today reported results for the second-quarter 2021. Second-Quarter Results (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2021 Mar. 31, 2021 Jun. 30, 2020 Sequential Year-on-year Revenue* $5,634 $5,223 $5,356 8% 5% Income (loss) before taxes - GAAP basis $542 $386 $(3,627) 40% n/m Net income (loss) - GAAP basis $431 $299 $(3,434) 44% n/m Diluted EPS (loss per share) - GAAP basis $0.30 $0.21 $(2.47) 43% n/m Adjusted EBITDA** $1,198 $1,049 $838 14% 43% Adjusted EBITDA margin** 21.3% 20.1% 15.6% 118 bps 561 bps Pretax segment operating income** $807 $664 $396 22% 104% Pretax segment operating margin** 14.3% 12.7% 7.4% 162 bps 694 bps Net income, excluding charges & credits** $431 $299 $69 44% 525% Diluted EPS, excluding charges & credits** $0.30 $0.21 $0.05 43% 500% Revenue by Geography International $4,511 $4,211 $4,224 7% 7% North America* 1,083 972 1,097 11% -1% Other 40 40 35 n/m n/m $5,634 $5,223 $5,356 8% 5% *Schlum

Wyss Center Partners With Artiria Medical to Accelerate a Novel Therapy for Cerebral Vasospasm23.7.2021 12:59:00 EEST | Press release

The Wyss Center and Artiria Medical today announced a new partnership to accelerate the translation of a novel technology that has the potential to reduce deaths and improve quality of life for stroke patients. Artiria Medical, an early-stage medical device company focused on disruptive neurovascular products, has been developing the technology and is now joining forces with the Wyss Center, a non-profit organization dedicated to bringing state-of-the-art therapies to the patient. The team has received support from the Swiss Innovation Agency, Innosuisse, to test and validate the efficacy of the therapy preclinically, in preparation for human clinical studies. Stroke is the third leading cause of disability worldwide with more than 80 million people living with long-term impairments as a result. Some strokes result in bleeding in the brain. Such hemorrhagic strokes can lead to severe cerebral vasospasm - an uncontrolled contraction of brain arteries - in the days that follow, depriving

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom