New Four-year Data Show Sustained Relapse Reduction by Chugai’s Enspryng in People With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced new longer-term efficacy and safety data for Enspryng® [generic name: satralizumab (genetical recombination)], a pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody created by Chugai. The data show Enspryng has a favourable benefit:risk profile and is effective in reducing relapses over four years of treatment in people with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), a rare debilitating disease that affects the central nervous system. Efficacy and safety results from the open-label extension (OLE) periods of the SAkuraStar and SAkuraSky studies, in addition to the design of SAkuraBONSAI, a new study in people with AQP4-IgG seropositive NMOSD who are treatment naïve, or where prior rituximab (or biosimilar) treatment has failed, will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
“The data show that the efficacy and safety of Enspryng, which inhibits IL-6 signaling, are sustained over time. NMOSD is a lifelong disease where prevention of relapse is crucial, and its treatment often lasts several years. We believe that these data provide important evidence to help patients and healthcare professionals continue treatment with Enspryng with confidence,” said Dr. Osamu Okuda, Chugai’s President and CEO. “In Japan, Enspryng became available for self-administration in September 2021, which allows patients to take treatment at home. We will continue providing information on the appropriate use of this drug so that Enspryng may further contribute to the treatment of NMOSD.”
The pivotal phase III SAkuraStar and SAkuraSky four year overall treatment data found that 73% and 71% of people with AQP4-IgG seropositive NMOSD treated with Enspryng remained relapse-free after 192 weeks (3.7 years), respectively, and 90% and 91% remained free from severe relapse*. These results demonstrate that the robust efficacy observed in the studies' double-blind periods is sustained longer-term for Enspryng as both a monotherapy and in combination with immunosuppressive therapy.
*Relapse associated with low likelihood of recovery resulting in permanent disability
The data also reinforce that the safety profile of Enspryng in the overall Enspryng treatment period of up to seven years, is comparable to the double-blind treatment periods in both SAkuraStar and SAkuraSky studies. Rates of adverse events and serious adverse events during the overall treatment periods were consistent with Enspryng and placebo in the double-blind treatment periods. No new safety signals were observed.
Roche is also launching SAkuraBONSAI, a multicentre, Phase 3b, international study, to further evaluate disease activity and progression using comprehensive imaging, biomarker and clinical assessments in NMOSD populations where further research is warranted. People with AQP4-IgG seropositive NMOSD, who are treatment-naïve or where prior rituximab (or biosimilar) treatment has failed, will be administered Enspryng monotherapy for two years and evaluated using clinical measures such as magnetic resonance imaging, optical coherence tomography and biomarkers of blood and cerebrospinal fluid.
Enspryng, created by Chugai, is a pH-dependent binding humanized anti-IL-6 receptor antibody, which was the first product developed by applying our proprietary recycling antibody technology. The drug is designed to prevent relapse of neuromyelitis optica spectrum disorder (NMOSD) by inhibiting the cytokine IL-6 which is a key driver in NMOSD. In two global phase III clinical studies in Neuromyelitis Optica and NMOSD, the primary endpoint was achieved with satralizumab either as combination therapy with baseline immunosuppressive treatment (SAkuraSky; NCT02028884) or as monotherapy (SAkuraStar; NCT02073279). These studies represent one of the largest clinical trial programs undertaken for this rare disease. Enspryng has been approved in 58 countries including Japan, the U.S. the EU and Canada.
About neuromyelitis optica spectrum disorder (NMOSD)1
NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord. The disease can lead to continual and significant decrease in quality of life due to permanent neurological disability. Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, pain leading to decreased quality of life. In some cases, attacks of NMOSD can result in death. Aquaporin-4 antibodies (AQP4-IgG), pathogenic antibodies, are detected in the blood of around 70-80% of people with NMOSD. AQP4-IgG is known to target and damage a specific central nervous cell type called astrocytes, resulting in inflammatory demyelinating lesions of the optic nerve(s), spinal cord and brain 2-5. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis 6-10.
Trademarks used or mentioned in this release are protected by law.
- Neuromyelitis optica spectrum disorder (NMOSD) Online. https://nmosd-online.jp/ Accessed Oct 2021. (Japanese only)
- Jarius S, Ruprecht K, Wildemann B et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: A multicentre study of 175 patients. J Neuroinflammation 2012;9:14.
- Lennon VA, Wingerchuk DM, Kryzer TJ et al. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet 2004;364:2106-12.
- Marignier R, Bernard-Valnet R, Giraudon P et al. Aquaporin-4 antibody-negative neuromyelitis optica: Distinct assay sensitivity-dependent entity. Neurology 2013;80:2194-200.
- Takahashi T, Fujihara K, Nakashima I et al. Anti-aquaporin-4 antibody is involved in the pathogenesis of NMO: a study on antibody titre. Brain 2007;130:1235-43.
- Chihara N, Aranami T, Sato W et al. Interleukin 6 signaling promotes anti-aquaporin 4 autoantibody production from plasmablasts in neuromyelitis optica. Proc Natl Acad Sci USA 2011;108:3701-6.
- Kimura A, Kishimoto T. IL-6: regulator of Treg/Th17 balance. Eur J Immunol 2010;40:1830-5.
- Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review. Int J Neurosci2016;126:1051-60.
- Takeshita Y, Obermeier B, Cotleur AC, et al. Effects of neuromyelitis optica-IgG at the blood-brain barrier in vitro. Neurol Neuroimmunol Neuroinflamm. 2016;4(1):e311.
- Obermeier B, Daneman R, Ransohoff RM. Development, maintenance and disruption of the blood-brain barrier. Nat Med 2013;19:1584-96.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
About Business Wire
(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
RIDDLE&CODE and Blockdaemon Join Forces to Unlock Next-Gen Industrial Tokenization Services21.10.2021 10:15:00 CEST | Press release
Leading European blockchain interface company RIDDLE&CODE and the largest crypto infrastructure platform for node management and staking Blockdaemon, announced today a strategic, long-term partnership that will focus on delivering next-gen industrial tokenization services. RIDDLE&CODE will integrate Blockdaemon's premium full node services to scale and enhance the tokenization capabilities of its Token Management Platform. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005053/en/ Tokenization is potentially the largest use case of blockchain that unlocks illiquid assets, simplifies their transfer and enables companies to expand and diversify portfolios. With a value that could exceed $24 trillion by 2027, it offers a range of benefits, including the development of new business models such as fractional ownership, sale and purchase of assets without middlemen, greater operational efficiency and overcoming geographic res
New Moody's ESG Solutions Tool Helps Meet EU Taxonomy Requirements21.10.2021 10:06:00 CEST | Press release
Moody’s ESG Solutions today launched EU Taxonomy Alignment Screening, a new data solution to help market participants meet the disclosure requirements of the European Union’s (EU) Taxonomy regulation. Moody’s built its tool from the ground up, an approach that sets the solution apart in this space and ensures that the underlying data is as closely aligned to the technical criteria of the EU Taxonomy as possible. "The responsible investment landscape is continually evolving due to new standards for disclosure practices and demand for ESG-labelled products,” said Sabine Lochmann, Global Head of Moody’s ESG Measures. “EU Taxonomy Alignment Screening is the latest addition to our suite of regulatory data solutions, which help market participants navigate regulatory requirements, create innovative financial products, and support efforts to build a more sustainable economy.” The EU Taxonomy provides a first-of-its-kind classification system for identifying environmentally sustainable activit
New Report from Gemserv and tado° Shows Smart Thermostats Most Cost Effective and Scalable Way to Decarbonise Homes in the EU’s Green Deal Renovation Wave21.10.2021 10:00:00 CEST | Press release
With heating and cooling of homes accounting for 21% of the EU’s energy consumption, European housing stock urgently needs decarbonising in order to lower emissions 55% by 2030 and achieve net-zero1 according to a new report from Gemserv and tado°. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211021005179/en/ Smart thermostats deliver over ten times as much annual carbon savings per €100 of up-front cost compared to the next best measure, an important factor in consumer decision-making. (Graphic: Business Wire) To realise these goals and reduce CO2 emissions, approximately €600 billion has been reserved in the EU’s Green Deal funds2. Decarbonisation is a huge challenge for governments across Europe, and any spending must be used as effectively and efficiently to not incur higher costs to the taxpayer. A new report produced by research consultancy Gemserv looked at the four most common methods of decarbonising homes in Euro
Vodafone Connects Its Customers With Thales’ Eco-SIM Card21.10.2021 08:00:00 CEST | Press release
Thales to supply Vodafone Group with Eco-SIM; a product whose card body is made out of 100% recycled plastic from refrigerator interiors. Vodafone initially plans to deploy Eco-SIM in ten countries1 in Europe and Africa. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211020006111/en/ Credit Vodafone Over 4.5 billion SIM cards are produced every year2, representing 20,000 tons of plastic – the equivalent weight of two Eiffel towers. Developed in partnership with Veolia, the global leader in ecological transformation, the Thales Eco-SIM was launched in 2020 and is made from 100% recycled polystyrene recovered from discarded refrigerators. Offering a second life to the refrigerator interiors, Thales enabled an independent and exclusive green plastic supply flow to Vodafone. Thales’ carbon offsetting program also ensures its innovative ‘green SIM’ is certified as carbon neutral3. As a result, the new contract will support Vodafo
Gaïa Rating - New Award for ESI Group's ESG Commitment21.10.2021 08:00:00 CEST | Press release
Regulatory News: Gaïa Research, a service of EthiFinance and a major player in the field of ESG rating (environment, social and governance) of French mid-sized listed companies, has awarded ESI Group (Paris:ESI), a global player in virtual prototyping, committed to a cleaner, safer, and more productive industry, the first Gaïa 2021 prize in the category of mid-cap companies with annual revenues under €150 million. This award received during the ceremony held on October 19th, 2021 in Paris, illustrates the efforts made by the Group to continuously improve its CSR commitments (social, societal, and environmental). 2021 was shaped by several significant actions for ESI Group, both within its governance, its environmental commitments, some in collaboration with Reforest'Action, and above all, with initiatives dedicated to its employees. Particularly shaken by the Covid-19 health crisis, the work-life balance was a field of action for ESI Group, which employs 1,200 people in about 20 countr
Boyd Corporation Acquires Siltec, Continues to Expand Global Material Science Portfolio21.10.2021 08:00:00 CEST | Press release
Boyd Corporation, a world-leading innovator of technologies in engineered materials and thermal management, today announced the acquisition of Siltec, a Weiler, Germany-based specialist in silicone compounding for custom products in the highly-regulated medical industry. The acquisition deepens and diversifies Boyd’s material science portfolio and further expands its European footprint. “Siltec’s dedicated team of scientists and technologists enhance Boyd competencies in silicone material science and the medical industry. We’ll leverage this expertise to accelerate innovation across Boyd’s material portfolio and adjacent high growth markets like industrial technology, eMobility and cloud data center where customers need high temperature resistant and durable solutions,” stated Boyd CEO Doug Britt. Boyd continues to invest in value-driven innovation and technology to create marketable differentiation for its customers. The addition of silicone compounding expertise further bolsters Boyd
ADVA manages supply constraints and grows revenues and profitability in Q3 202121.10.2021 07:00:00 CEST | Press release
ADVA (ISIN: DE0005103006, FSE: ADV), a leading provider of open networking solutions for the delivery of cloud and mobile services, reported its financial results for Q3 2021 ended on September 30, 2021. The results have been prepared in accordance with International Financial Reporting Standards (IFRS). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211020005879/en/ Brian Protiva, CEO, ADVA (Photo: Business Wire) Q3 2021 financial summary1 (in thousands of EUR) Q3 Q3 Change Q2 Change 2021 2020 2021 Revenues 151,777 146,676 3.5% 149,354 1.6% Pro forma gross profit 52,153 51,930 0.4% 57,274 -8.9% in % of revenues 34.4% 35.4% -1.0pp 38.3% -3.9pp Pro forma operating income 13,012 11,053 17.7% 14,415 -9.7% in % of revenues 8.6% 7.5% 1.1pp 9.7% -1.1pp Operating income (loss)2 9,496 9,768 -2.8% 13,036 -27.2% Net income 18,478 6,671 177.0% 12,001 54.0% (in thousands of EUR) Sep. 30 2021 Sep. 30 2020 Change Jun. 30 2021 Change Cash