Business Wire

Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018

Jaa

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that results from the phase III study of satralizumab (development code: SA237), SAkuraSky Study (NCT02028884), were presented at the Congress of European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2018 held in Berlin, Germany from October 10 to 12. Satralizumab is a humanized investigational recycling anti-IL-6 receptor monoclonal antibody for the treatment of neuromyelitis optica spectrum disorder (NMOSD), which currently has no approved treatments.

“These positive pivotal results for satralizumab, showing a significant reduction in relapses in patients, are a significant positive step in the potential treatment of NMOSD,” said Dr. Takashi Yamamura, Director, Department of Immunology, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo. “Many people with NMOSD are suffering from frequent relapses and often persistent motor dysfunction and loss of sensation, and end up relying on wheelchairs or going blind. The medical community hopes that this potential new medicine may alleviate the condition and improve the everyday lives of people who currently have no approved treatment options.”

The phase III study results for SAkuraSky study showed:

  • Satralizumab on top of immunosuppressive therapy significantly reduced the risk of relapse by 62% (hazard ratio = 0.38 [95% confidence interval: 0.16-0.88], p=0.0184 [stratified log-rank test]) in patients with NMOSD including anti-aquaporin-4 (AQP4) antibody positive (AQP4 Ab positive) and negative (AQP4 Ab negative) patients, achieving the primary endpoint of time to first protocol-defined relapse (PDR) in the double-blind period. The proportion of relapse free at weeks 48 and 96 was 88.9% and 77.6% with satralizumab and 66.0% and 58.7% with placebo, respectively.
  • In a prespecified subgroup analysis, satralizumab showed a 79% risk reduction (N=55, hazard ratio=0.21 [95% confidence interval: 0.06-0.75]) of PDR compared to placebo in the NMOSD AQP4 Ab positive subgroup. The proportion of relapse free at weeks 48 and 96 was 91.5% and 91.5% with satralizumab and 59.9% and 53.3% with placebo, respectively. For the NMOSD AQP4 Ab negative subgroup, satralizumab showed a 34% risk reduction (N= 28, hazard ratio= 0.66 [95% confidence interval: 0.20-2.23]) of PDR compared to placebo, and the proportion of relapse free at weeks 48 and 96 was 84.4% and 56.3% with satralizumab, and 75.5% and 67.1% with placebo, respectively.
  • Throughout the mean treatment duration of approximately 2 years, satralizumab showed a favorable safety profile. The proportion of patients experiencing serious adverse events, including serious infections, was similar in patients treated with satralizumab or placebo. No death or anaphylactic reactions were observed.

“The positive phase III results for satralizumab suggests that IL-6 inhibition should be an effective therapeutic approach for NMOSD,” said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. “NMOSD is a disease with significant unmet medical needs. Although progression of the disease may lead to blindness and motor dysfunction, there are no approved drugs available. We continue our efforts so that we can hopefully bring this treatment option to people living with this devastating disease.”

SAkuraSky Study

Summary:

A phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab added to baseline therapy in patients with NMOSD

 
   

Primary Endpoint

Time to first protocol-defined relapse adjudicated by an independent review committee in the double-blind period

 

Main Secondary Endpoints

Change in Visual Analogue Scale (VAS) score for pain
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score

Study Design:

  • 83 male and female patients aged from 13 to 73 years were randomized.
  • Patients were randomized to either of the following two treatment groups in a 1:1 ratio. Satralizumab (120 mg) or placebo added to baseline therapy (azathioprine, mycophenolate mofetil and/or corticosteroids). Both treatments were subcutaneously administered at Week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals.
  • The double-blind period ended when the total number of protocol-defined relapse reached 26. After completion of the double-blind period, patients in both groups were able to continue treatment with satralizumab in an open-label extension period.
  • Patients with neuromyelitis optica (as defined by diagnostic criteria in 2006) and those with NMOSD (as defined by diagnostic criteria in 2007) with anti- AQP4 antibodies, were enrolled.

About Neuromyelitis Optica Spectrum Disorder (NMOSD)
Neuromyelitis optica spectrum disorder (NMOSD) is a rare, lifelong, and debilitating autoimmune disease of the central nervous system (CNS) characterized by inflammatory lesions in the optic nerves and spinal cord. 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, and loss of quality of life. In some cases, attacks of NMOSD result in death.

NMOSD pathogenesis is thought to involve AQP4-IgG autoantibody entry into the CNS, however approximately one-third of patients with NMOSD are AQP4-IgG seronegative. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis.

Diagnostic criteria introduced in 2006 for neuromyelitis optica were characterized by inflammation of the optic nerve (optic neuritis) and the spinal cord (myelitis). These were revised in 2007 with the definition of NMOSD, proposed for diseases with either optic neuritis or myelitis. In 2015, the definition of NMOSD further revised to include a broader spectrum of disease. The diagnostic term NMOSD is now widely used.

References

  • 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.
  • Wingerchuk DM, Lennon VA, Pittock SJ, et al. Revised diagnostic criteria for neuromyelitis optica. Neurology 2006;66:1485-9.
  • Wingerchuk DM, Lennon VA, Lucchinetti CF, et al. The spectrum of neuromyelitis optica. Lancet Neurol 2007;6:805 15.
  • Wingerchuk DM, Banwell B, Bennett JL et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology 2015;85:177-89.

About Chugai
Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area.
In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.
The consolidated revenue in 2017 of Chugai totalled 534.2 billion yen and the operating income was 103.2 billion yen (IFRS Core basis).
Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.

All trademarks used or mentioned in this release are protected by law.

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Tomoko Shimizu
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp
***
For US media
Chugai Pharma USA Inc.
Casey Astringer
Tel: +1-908-516-1350
E-mail: pr@chugai-pharm.com
***
For European media
Chugai Pharma France SAS
Nathalie Leroy
Tel: +33-1-56-37-05-21
E-mail: pr@chugai.eu
***
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Susan Chou
Tel: +886-2-2715-2000
E-mail: pr@chugai.com.tw
***
For Investors
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
Toshiya Sasai
Tel: +81-3-3273-0554
E-mail: ir@chugai-pharm.co.jp

Tietoja julkaisijasta

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

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Cooper & Turner Announces Potential Combination with Beck Industries19.6.2019 22:32:00 EESTTiedote

Andaray (Holdings) Limited and its direct and indirect subsidiaries (“Cooper & Turner”) have entered into an agreement with Beck Industries (“Beck”) for potential combination of the two groups. The contemplated combined entity aims to be the first truly global manufacturer of safety critical fasteners, together supporting a broader range of industries – including renewable energy, tunneling, construction, rail, heavy equipment, downstream oil & gas, power generation and nuclear, among others. Headquartered in Sheffield, England, Cooper & Turner serves a global customer base with manufacturing and distribution operations across the European Union, China and North America. This worldwide network enables Cooper & Turner to offer a seamless, one-stop shop solution for industrial fasteners that meet the highest levels of quality. Beck, a France-based manufacturer and distributor of fully certified, high-security bolting components, has built a global operation that complements and expands t

Tinubu Square Appoints Sophie Riottot as Group Sales Director19.6.2019 20:02:00 EESTTiedote

Tinubu Square, a leading provider of credit insurance, surety and trade finance solutions, has announced the appointment of Sophie Riottot as Group Sales Director. This is a strategic engagement for the company, which is restructuring its sales approach to reinforce its rapid global growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190619005634/en/ Sophie Riottot, new Group Sales Director at Tinubu Square (Photo: Business Wire) Sophie Riottot brings a wealth of experience to Tinubu Square. She joins the company from Dhatim, a French start-up specializing in AI-powered invoice services, where she was responsible for sales strategy and partnership development. Prior to this, she was with Microsoft for over 17 years, in a variety of prominent sales and management positions, including Head of Finance in the Services Division. As a member of the executive committee at Tinubu Square, Sophie will be responsible for spearheadin

ExaGrid Voted “Enterprise Backup Hardware Product of the Year”19.6.2019 20:00:00 EESTTiedote

ExaGrid®, a leading provider of intelligent hyperconverged storage for backup, today announced that it has been voted Storage Magazine’s “Enterprise Backup Hardware Product of the Year” at its annual awards ceremony Storries XVI. Winners are determined by public vote, so receipt of this award is especially important; it heralds the collective voices of ExaGrid’s customers and partners, and further validates the excellence of ExaGrid’s differentiated product architecture and superior customer support model. “We’re honored to accept this award from Storage Magazine,” said Bill Andrews, President and CEO of ExaGrid. “ExaGrid’s deduplication and its scale-out architecture provides customers with a consistent backup window regardless of data growth, which is especially important in today’s ever-changing enterprise environments. The scale-out approach also eliminates forklift upgrades and forced product obsolescence. Our unique Landing Zone retains the most recent backup in its full undedupl

Luxury Pre-War Elevator Building in Prestigious Brooklyn Heights Offered for Sale19.6.2019 19:12:00 EESTTiedote

Holliday Fenoglio Fowler, L.P. (HFF) announces it has been selected to exclusively market the sale of 25 Monroe Place, a 12-story, 67-unit, luxury apartment building located in the Brooklyn Heights neighborhood of Brooklyn, New York. This offering provides a rare opportunity to acquire a trophy asset in the most sought-after neighborhood in Brooklyn. The vast majority of the property is comprised of fair-market units not subject to rent stabilization. 25 Monroe Place is situated in the Brooklyn Heights historic district, which provides immediate access to Manhattan, the Brooklyn Waterfront, Brooklyn Bridge Park, Downtown Brooklyn and DUMBO. Brooklyn Heights is characterized by charming brownstones and plush tree-lined streets, and the property is surrounded by medium- and low-density buildings that provide water and Manhattan skyline views. Built in 1938, 25 Monroe Place combines pre-war architectural elements and spacious apartment layouts with newly upgraded condo-quality finishes, i

Shopify Unveils New Innovations to Transform Commerce for Merchants and Consumers Globally19.6.2019 18:30:00 EESTTiedote

Today, Shopify Inc. (NYSE:SHOP) (TSX:SHOP), the leading multi-channel commerce platform, unveiled the latest in commerce technology at Shopify Unite, the annual conference that brings together the company’s global partner and developer community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190619005550/en/ Shopify Fulfillment Network (Graphic: Business Wire) “Shopify’s real power comes from the variety and strength of our ecosystem,” said Shopify CEO Tobi Lutke. "Unite gives our developer and partner community access to our product roadmap. Together, and only together, we can shape the future of commerce and empower entrepreneurs around the world.” This year, Shopify is transforming commerce by announcing platform enhancements and updates focused on giving direct-to-consumer brands everything they need to build and manage a business. Shopify’s innovations include a newly updated Shopify Plus platform for enterprise brands

Geri Horner Test Drives RockStar Suites aboard Virgin Voyages’ Scarlet Lady19.6.2019 17:01:00 EESTTiedote

Virgin Voyages is upping the game for its top suites aboard the highly anticipated Scarlet Lady, with new offerings to ensure that Mega RockStars won’t have to worry about a thing during their voyage. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190619005107/en/ Geri Horner of the Spice Girls testing out Virgin Voyages Mega Rockstar Suites in New Video (Photo: Business Wire) Geri Horner Test Drives RockStar Suites In celebration of the expanded offerings, the brand has today released exclusive video content of the suites, which features Virgin Group founder, Sir Richard Branson, and legendary British pop star, Geri Horner, of the hugely successful girl group, the Spice Girls. The video documents Horner test driving the Virgin Voyages ‘Gorgeous Suite,’ one of the ship’s most glamorous cabins, as a favor to her longtime friend, Branson. Following Horner’s journey through the suite, the footage chronicles her full RockStar ex

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme