Business Wire

Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology

Share

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the results of the SAkuraStar Study (NCT02073279), a global phase III clinical study of satralizumab (development code: SA237) were published on April, 22 (local time) in The Lancet Neurology. Satralizumab is an anti-IL6 receptor humanized recycling antibody under development for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The phase III study examined the efficacy and safety of satralizumab as monotherapy for adults with NMOSD.
Article: https://doi.org/10.1016/S1474-4422(20)30078-8

“The longer-term efficacy in satralizumab monotherapy study reinforces the important role of IL-6 inhibition in treating NMOSD following the previous combination therapy study,” said Chugai’s President and COO, Dr. Osamu Okuda. “We are collaborating with Roche to obtain global regulatory approval this year so that we can bring satralizumab as a new treatment option to patients as soon as possible.”

In the SAkuraStar Study, satralizumab significantly reduced the risk of relapse by 55% (hazard ratio=0.45 [95% confidence interval: 0.23-0.89], p=0.018 [stratified log-rank test]) in the overall population, representative of the broad real-world spectrum of NMOSD patients (including AQP4-IgG seropositive and seronegative patients), achieving the primary endpoint of time to first protocol-defined relapse in the double-blind period. Importantly, 76.1%, 72.1% and 62.8% of patients on satralizumab were relapse-free at weeks 48, 96 and 144 compared to 61.9%, 51.2% and 34.1 with placebo, respectively. In a prespecified subgroup analysis for time to relapse, hazard ratio of satralizumab to placebo in AQP4-IgG seropositive patients was 0.26 (N=64, 95% confidence interval: 0.11-0.63). The proportion of serious adverse events was similar between the satralizumab and placebo treatment groups. The most common adverse events in the satralizumab group were urinary tract infection and upper respiratory tract infection.

SAkuraStar Study (NCT02073279)
Summary:
A phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab administered to patients with NMOSD

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

Study design:

  • 95 male and female patients aged from 20 to 70 years were randomized.
  • Patients were randomized to satralizumab or placebo in a 2:1 ratio. Satralizumab (120 mg) or placebo was subcutaneously administered at Week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals.
  • The double-blind treatment period ended when the total number of protocol-defined relapse (PDR) had reached 44 or at 1.5 years after the enrollment of the last patient, whichever occurred first. After experiencing a PDR or completion of the study, patients in both groups were offered treatment with satralizumab in an open-label extension period.
  • Patients with AQP4-IgG seropositive or seronegative neuromyelitis optica (NMO)* and those with AQP4-IgG seropositive NMOSD were enrolled.
    *NMO defined in 2006

About neuromyelitis optica spectrum disorder (NMOSD)

NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and cause continual and significant decrease in quality of life due to permanent neurologic disorders 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. Aquaporin-4 antibodies (AQP4-IgG), pathogenic antibodies, are detected in at least two-thirds of NMOSD patients. 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 1-4. The inflammatory cytokine IL-6 is now emerging as an important factor in NMOSD pathogenesis 5-9.

Diagnostic criteria introduced in 2006 for NMO 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 10.

About satralizumab

Satralizumab, created by Chugai, is an anti-IL-6 receptor recycling antibody. The drug is expected to prevent relapse of NMOSD by inhibiting IL-6 signal transduction which is deeply related to the pathology. In two global phase III clinical studies in NMO and NMOSD patients, the primary endpoint was achieved with satralizumab either as an add-on therapy to baseline immunosuppressant treatment (NCT02028884) or as monotherapy (NCT02073279). These studies represent one of the largest clinical trial programs undertaken for this rare disease. Satralizumab is designated as an orphan drug for the treatment of NMO and NMOSD in Japan, and for the treatment of the same disease group in Europe and the U.S. In addition, it has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration in December 2018. The regulatory applications were accepted for review by EMA and FDA in 2019. The regulatory application in Japan was filed in 2019.

Sources
1. 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.
2. Lennon VA, Wingerchuk DM, Kryzer TJ et al. A serum autoantibody marker of neuromyelitis optica: distinction from multiple sclerosis. Lancet 2004;364:2106-12.
3. 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.
4. 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.
5. 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.
6. Kimura A, Kishimoto T. IL-6: regulator of Treg/Th17 balance. Eur J Immunol 2010;40:1830-5.
7. Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review. Int J Neurosci2016;126:1051-60.
8. 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.
9. Obermeier B, Daneman R, Ransohoff RM. Development, maintenance and disruption of the blood-brain barrier. Nat Med 2013;19:1584-96.
10. Wingerchuk DM, Banwell B, Bennett JL et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology 2015;85:177-89.

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 U.K. Ltd.
Carter Westwood
Tel: +44-20-8987-5680
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

About Business Wire

Business Wire
Business Wire



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

Saudi Urban20 Chair Wishes Italy ‘Buona Fortuna’ With the 2021 Urban20 Presidency26.11.2020 14:47:00 CETPress release

TheUrban20 (U20) Chair, His Excellency Fahd Al-Rasheed, President of the Royal Commission for Riyadh City has today wished his Italian counterparts good luck or “Buona Fortuna” as Italy prepares to take up the reins of the 2021 G20 Presidency and the engagement group of cities, the U20. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005650/en/ HE Fahd Al-Rasheed, chair of U20 Riyadh 2020 - (Photo - AETOSWire) “The city of Riyadh is immensely proud and honored to have Chaired the 2020 U20. We are proud of the progress we made together as the U20 of 42 cities and 30 think tanks, universities, and multi-lateral entities. We collaborated, innovated and found common ground. We discussed challenges and solutions experienced by cities across every continent. We focused on the common goal of rebuilding better. As we worked to bring urban issues to the fore, a record 39 mayors and representatives of leading cities endorsed the

DEWA Innovation Centre and 800MW 3rd Phase of the Mohammed bin Rashid Al Maktoum Solar Park Inaugurated26.11.2020 14:31:00 CETPress release

HH Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, has inaugurated Dubai Electricity and Water Authority’s (DEWA’s) Innovation Centre and the 800MW third phase of the Mohammed bin Rashid Al Maktoum Solar Park, the largest single-site solar park in the world. The solar park has a planned capacity of 5,000MW by 2030, with investments up to AED50 billion. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005645/en/ DEWA Innovation Centre and 800MW 3rd phase of the Mohammed bin Rashid Al Maktoum Solar Park inaugurated (Photo: AETOSWire) HH Sheikh Mohammed bin Rashid Al Maktoum was briefed by HE Saeed Mohammed Al Tayer, MD & CEO of DEWA, about the Innovation Centre, which is a global hub for renewable and clean energy innovation. It supports innovation and creativity in clean and renewable energy, promotes sustainability, develops Emirati talent and enhances the UAE’s com

Leveraging Its Mobile ID, IDEMIA Brings Digital Travel Credentials to Life26.11.2020 14:30:00 CETPress release

Digital Travel Credentials make traveling between airports and airlines a more enjoyable experience and bolsters passenger trust in airport services and systems. On 10-11 November 2020, at the ICAO virtual conference, IDEMIA demonstrated with an airline partner its breakthrough innovation capabilities to present a fully operational solution, bringing DTC to life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005534/en/ (Photo: Buiness Wire) Leveraging its Mobile ID solution and passenger flow facilitation solutions, IDEMIA simulated a passenger DTC for check in and smart boarding. Passengers can speed through all airport touchpoints thanks to fast and ultra-secure biometric identification. IDEMIA’s DTC treat private data with the same security level as for paper passports. “This DTC demonstrator illustrates the innovative capabilities of IDEMIA to perform a highly secure, reliable and smooth identity verification of t

Egle Therapeutics Identifies First Novel Regulatory T-cell Targets in Research Alliance with Takeda26.11.2020 11:30:00 CETPress release

Egle Therapeutics SAS (Egle), an emerging biotechnology company focused on developing first-in class immunotherapies targeting immune suppressor regulatory T-cells (Tregs) for oncology and autoimmune diseases, today announces that it has achieved the first milestone in its strategic research alliance with Takeda Pharmaceutical Company Limited (“Takeda”). In the course of the strategic research alliance that was announced in June 2020, Egle will validate novel tumor-infiltrating regulatory T-cell (Treg) targets against which Takeda will develop potential therapies. Egle has leveraged its unique bioinformatic and translational capabilities to successfully identify targets that will now be pursued under the terms of the alliance. Upon achievement of the target identification, Egle will receive an R&D milestone payment and investment from Takeda. Luc Boblet, CEO of Egle, commented “Reaching this first technical milestone marks our positive progress towards our joint goal with Takeda, of cr

Technology Entrepreneurs Choose Chengdu as Destination and Benefit From the City’s International Business-Friendly Environment26.11.2020 09:23:00 CETPress release

Chengdu has long had an international reputation as a highly livable city. In recent years, Chengdu has also cultivated a business-friendly environment aligned with international standards, making the city fertile soil for enterprise development, especially in the tech sector. XGIMI Technology, a Chengdu-based leading provider of multi-functional smart projectors and laser TVs in China, attributed part of its success to Chengdu’s favorable environment, helping the firm to grow and in 2018 surpass global giants Epson and Sony in the Chinese projector market for the first time. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201126005495/en/ XGIMI Technology Founder Mr. Zhong Bo (Photo: Business Wire) According to data on China’s projector market in the first half of 2020 released by IDC, XGIMI ranked first in terms of shipments and sales, with a market share of 22%. Five XGMI models feature in the top ten projectors by shipmen

Lexon’s Oblio Named as One of TIME’s 100 Best Inventions Of 202026.11.2020 08:57:00 CETPress release

20 years after making the cover of TIME with their flagship Tykho radio, French design brand Lexon is back on the prestigious publication to reiterate its mission to continuously create disruptive, useful and affordable design objects that improve our daily lives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201125005899/en/ Oblio (Photo: Business Wire) More than just highlighting the groundbreaking French invention, TIME award confirms Oblio’s position as a must-have innovation for today’s world, as it has been crafted in-house primarily as a sleek UV-C sanitizer to prevent the spread of harmful viruses and bacteria that are found on our smartphones, using its built-in UV-C LED technology located on its front interior. UV-C LEDs destroy and eradicate the DNA of microorganisms found in viruses, bacteria, mold, and germs. Capable of fully sanitizing a single surface at a time, Oblio can deliver a 360° disinfection by simply

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