Kyowa Kirin to Present Atopic Dermatitis Clinical Data from KHK4083/AMG 451 Phase 2 Study at The European Academy of Dermatology and Venereology 30th Congress
13.9.2021 16:00:00 EEST | Business Wire | Press release
Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) , a global specialty pharmaceutical company creating innovative medical solutions utilizing the latest biotechnology, today announced detailed data from a Phase 2 study of KHK4083/AMG 451 will be highlighted in late-breaking oral presentation at the European Academy of Dermatology and Venereology 30th Virtual Congress to be held September 29 – October 2, 2021. KHK4083/AMG 451 is a potential first-in-class anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases.
Presentation Title:
Efficacy and safety results of KHK4083/AMG 451 (anti-OX40 mAb) in subjects with moderate to severe atopic dermatitis: a phase 2, multicentre, randomized, double-blind, parallel-group, placebo-controlled study
Submission Topic: 5. Atopic Dermatitis/Eczema
Session date and time: Saturday 2 October 2021, 10.00 - 11.00(CEST)
Primary Author: Emma Guttman-Yassky, M.D./Ph.D., System Chair for the Department of Dermatology and Waldman Professor of Dermatology and Immunology, Icahn School of Medicine at Mount Sinai and Director of the Center for Excellence in Eczema, and the Laboratory of Inflammatory Skin Diseases at Mount Sinai.
The abstract will be available on the EADV Congress website.
The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
About KHK4083/AMG 451
KHK4083/AMG 451 is an anti-OX40 fully human monoclonal antibody engineered with Kyowa Kirin’s patented POTELLIGENT® defucosylation technology to enhance its antibody-dependent cellular cytotoxicity (ADCC) activity. The initial KHK4083/AMG 451 antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology.
KHK4083/AMG 451 targets and inhibits the activity of the OX40 receptor expressed on the surface of effector T-cells, and has been shown to deplete activated OX40+ T-cells by ADCC. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in their development. Kyowa Kirin antibodies powered by POTELLIGENT technology with ADCC activity are currently marketed in several other therapeutic areas, including Oncology and Asthma. This potent antibody-enhancement platform is also licensed to numerous third parties throughout the biopharmaceutical industry.
On June 1, 2021, Kyowa Kirin entered into an agreement with Amgen (NASDAQ: AMGN) to jointly develop and commercialize KHK4083/AMG 451. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. If approved, the companies will co-commercialize the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia.
An overview of the KHK4083/AMG 451 Phase 2 Study
A Phase 2, multicenter, randomized, double-blind, and placebo-controlled clinical study (NCT03703102) was conducted in the U.S., Japan, Canada, and Germany to investigate the efficacy and safety of KHK4083/AMG 451. The study included 274 patients with moderate-to-severe atopic dermatitis, who were not adequately controlled with topical agents. The primary endpoint of the study was "percent change from baseline in Eczema Area and Severity Index (EASI) 1 at 16 weeks”.
About OX40
OX40 is a co-stimulatory molecule and a member of the tumor necrosis factor receptor (TNFR) superfamily. It has been reported that activated effector T cells express OX402,3 and are present in the lesions of patients with atopic dermatitis4. Professor Michael Croft, Ph.D., who is Director, Scientific Affairs, La Jolla Institute for Immunology helped identify that OX40 plays an important role in T cell proliferation, survival and formation of memory T cells5.
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, we apply cutting-edge science including expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/.
Kyowa Kirin International is a subsidiary of Kyowa Kirin Co., Ltd.
References
- Hanifin JM.; Thurston M.; Omoto M.; Cherill R.; Tofte SJ.; Graeber M: The eczema area and severity index（EAS）: assessment of reliability in atopic dermatitis. EASI Evaluator Group: Exp Dermatol, 2001; 10: 11-18.
- Croft, M.; So, T.; Duan, W.; Soroosh, P.: The significance of OX40 and OX40L to T-cell biology and immune disease. Immunol: Rev. 2009, 229, 173–191.
- Croft, M. Control of Immunity by the TNFR-Related Molecule OX40 (CD134): Annu. Rev. Immunol. 2010, 28, 57–78.
- Masutaka F.; Mihoko F. OX40L–OX40 Signaling in Atopic Dermatitis: J. Clin. Med. 2021, 10, 2578
- Gramaglia I; Jember A; Pippig SD; Weinberg AD, Killeen N; Croft M: The OX40 Costimulatory Receptor Determines the Development of CD4 Memory by Regulating Primary Clonal Expansion: J Immunol 2000: 165 (6) 3043-50; DOI: 10.4049/jimmunol.165.6.3043
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210913005356/en/
Contact information
Hiroki Nakamura (Global, Japan), +81-3-5205-7205
Lauren Walrath (North America), +1-646-526-4454
Stacey Minton (EMEA), +44 (0) 7769 65607
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
Fi Expands International Footprint to 38 Countries Worldwide2.6.2026 20:25:00 EEST | Press release
Fi, the leader in smart pet technology, today announced a major international expansion, bringing its AI-powered GPS pet wearables and connectivity network to 38 countries across North America and Europe. Fi devices are now available for purchase in 29 markets, including newly added countries such as Finland, Sweden, Denmark, Austria, Belgium, the Netherlands, Romania, Slovakia, and Latvia. Through Fi's international connectivity network, customers can also use Fi in Switzerland, Norway, Liechtenstein, Iceland, and Turkey, bringing Fi's total coverage footprint to 38 countries. The expansion reflects growing demand from pet owners who want reliable connectivity and health insights, whether they're at home or traveling abroad. "Wherever your pet roams, Fi should work," said Jonathan Bensamoun, Founder and CEO of Fi. "As more pet owners travel internationally and expect seamless connectivity, we're expanding Fi's footprint to help them stay connected to their pets across more of Europe a
XFolio AI Acquires Absolute Payment Solutions to Unify Treasury and Payments for UK Corporates2.6.2026 20:16:00 EEST | Press release
XFolio AI (xfolio.ai), a Paris-based treasury and cash management technology group, has acquired Absolute Payment Solutions (APS) (https://www.absolutepayments.com/), one of a select number of Pay.UK-accredited Bacs service providers in the UK. This acquisition creates an integrated platform spanning Bacs and all payment types, open banking, risk management, and treasury—giving UK corporates of all sizes the tools to manage cash and execute payments in one place. APS’s Bacs accreditation underpins payment services relied upon daily by organisations across both the public and private sectors, from SMEs running payroll and direct debit collections to large corporates processing high-volume payment flows. While enterprise payment platforms often demand significant scale and budget, and lighter solutions trade capability for speed of setup, APS and XFolio together deliver accredited Bacs infrastructure combined with advanced treasury intelligence across SWIFT, API, H2H, and EBICS rails—wit
Amazfit Introduces a New Era of Hybrid Training with Balance 3 and Balance Ultra2.6.2026 20:00:00 EEST | Press release
Amazfit, a leading global smart wearable brand owned by Zepp Health, today unveiled the Amazfit Balance 3 and Amazfit Balance Ultra, the newest additions to the Balance series and the hero watches for Amazfit’s new Hybrid Training System, connecting performance tracking with intelligent training guidance through the Zepp App. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602329170/en/ Built around how modern athletes train today, Balance 3 and Balance Ultra are designed for people balancing strength, endurance, recovery, work, stress, and daily life. The devices serve as the engine layer of the connected Hybrid Training ecosystem, capturing how users train, recover, and respond over time. The products were unveiled at a launch event in New York during a panel hosted by leading voices from the fitness and HYROX community. Built around how modern athletes train today, Balance 3 and Balance Ultra are designed for people bal
Mouser's Rise of the Robots Program Explores Humanoid Design Considerations2.6.2026 18:19:00 EEST | Press release
Mouser Electronics, Inc., the authorized global distributor with the newest electronic components and industrial automation products, today announced the latest installment of its Empowering Innovation Together (EIT) technology series, Rise of the Robots, which explores key technologies behind humanoid robots and their potential for transformation. The series shares how these robots have progressed from simple machinery to critical tools used in caregiving, industrial automation, education, and even in the harshest environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602293561/en/ The latest EIT installment explores the engineering design process, system integration challenges, and the role of legacy infrastructure, safety, and ROI in shaping scalable humanoid robot deployment. While science fiction has long envisioned robots resembling humans, recent advances in sensing, actuation, AI, embedded computing, and pow
Blue Cloud Ventures Announces Final Close of Blue Cloud Ventures V2.6.2026 17:35:00 EEST | Press release
Blue Cloud Ventures (BCV), a venture growth firm focused on investing in enterprise software companies, announced the final close of its fifth fund, Blue Cloud Ventures V (BCV V). This milestone reinforces the firm’s continued mission to back category-defining companies that are poised to thrive in the age of AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602186634/en/ At the core of BCV’s strategy is building deep conviction in and backing companies that possess the potential to define or reshape entire industries. With BCV V, the firm is doubling down on its AI-first investment thesis, aiming to back and support visionary teams on their long-term growth journey as they build the systems that will serve as the backbone of the modern enterprise. Blue Cloud typically invests between $10 and $30 million as a lead, co-lead, or co-investor. Beyond support with strategy, recruiting, and customer introductions, the firm pro
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