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 SISCO1 (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)

SYLVANTis 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 SYLVANTglobally. EUSA Pharma has granted BeiGene, Ltd., exclusive development and commercialization rights to SYLVANTin Greater China.

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

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

SYLVANTis 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

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 21:14:00 CET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

LambdaTest Launches The Phoenix Project, an Employee Resource Group for Women28.3.2024 16:00:00 CET | Press release

LambdaTest, a leading cloud-based unified testing platform, announced the launch of The Phoenix Project, an Employee Resource Group (ERG) dedicated to supporting and promoting the success of its female employees. “LambdaTest is committed to fostering a diverse, inclusive, and equitable workplace where all employees feel valued and empowered to reach their full potential,” said Chandini Chopra, VP of People and Culture at LambdaTest. “The Phoenix Project is a critical step towards achieving this goal by providing a platform for professional development, networking, and mentorship, especially for our women employees.” The Phoenix Project Aims To: Offer professional development workshops, networking opportunities, and dedicated time off for women to participate in ERG initiatives. Provide mentorship programs connecting senior female employees with mentees. Promote leadership development among women within the company. Create a sense of community for women in the workplace. Leadership and

The reopening of the Yokohama Museum of Art adds another innovative and distinctive venue for events in Yokohama28.3.2024 16:00:00 CET | Press release

After extensive renovations, the iconic Yokohama Museum of Art has reopened its doors to visitors from all over the world. The museum’s reopening paves the way to new and closer collaboration with international events in Yokohama. This extraordinary venue is the ideal setting for a one-of-a-kind gathering, in part, supported by the Yokohama Convention & Visitors Bureau (hereinafter YCVB). The Yokohama Museum of Art Founded in 1989, the Yokohama Museum of Art collects over 14,000 works of art that reflect the many facets of life in Yokohama—past, present, and future. The reopening of the museum coincides with the Yokohama Triennale, an international exhibition featuring contemporary artists whose decentralized exhibits turn the entire metropolis into an art museum. The 8th Yokohama Triennale is being held from March 15 to June 9, 2024, with the Yokohama Museum of Art being a pivotal venue for the exhibition. With the museum firmly back on the map as Yokohama’s leading artistic venue, YC

Eight new sustainability-themed experiences—exclusive to Yokohama—for convention participants28.3.2024 16:00:00 CET | Press release

In a survey conducted by Yokohama Convention & Visitors Bureau (hereinafter YCVB), many convention attendees expressed particular interest in Yokohama’s culture, sightseeing spots, and local cuisine. In response, YCVB has developed eight new Yokohama Tours for event attendees to enjoy during their free time in Yokohama, keeping in line with our ethos of sustainability. Noge Area Bar-Hopping Tour, complete with guide Known affectionately by locals as Yokohama’s kitchen, Noge is a bustling nightlife spot that is home to over 600 izakaya (Japanese-style pubs). A knowledgeable local guide will lead participants to all the hidden gems in Noge, where they can indulge in distinctive, delicious pub-style food and drink. With easy on-foot accessibility, participants can rest assured this fun night out won’t impact their carbon footprint. Soto Zen Tour of Sojiji, head temple of the Soto Zen school As a prominent Zen sect in Japan, Soto Zen provides one of the best Zen wellness experiences. Durin

Nordson EFD Releases New 3-Axis Automated Fluid Dispensing Systems28.3.2024 15:00:00 CET | Press release

Nordson EFD, a Nordson company (NASDAQ: NDSN) and leading precision fluid dispensing systems manufacturer is proud to announce the new GVPlus and PROX families of automated fluid dispensing products. Both robotic solutions share a focus on motion, workspace, repeatability, payload, setup, and vision technology enhancements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240305726899/en/ The GV Series offers market-leading dimensional positional accuracy and deposit placement repeatability. (Photo: Business Wire) The new GVPlus automated fluid dispensing solution offers improved repeatability, bigger payloads with simplified setup requirements, and superior vision capabilities. Repeatability is now best-in-class at 8 μm, improving repeatability to ±0.008 mm. Setting up the robot is easier due to a new dual mounting flange that enables a tool payload of up to 4.5 kg (10 lbs). When paired with the working area of 400 mm x 400 m

HiddenA line styled icon from Orion Icon Library.Eye