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
BTG Pactual Timberland Investment Group Raises US$1.24 Billion for Largest Reforestation Fund to Date[1]28.4.2026 18:00:00 EEST | Press release
BTG Pactual Timberland Investment Group (BTG Pactual TIG), one of the world’s largest timberland managers, today announced the close of fundraising for its Latin American Reforestation Strategy, reaching US$1.24 billion in commitments. This represents the largest reforestation fund closed to date,1 providing a model for large-scale reforestation and restoration that seeks to deliver durable climate impact, tangible benefits for rural communities, biodiversity outcomes, and sustainable commercial production. Global environmental organization Conservation International serves as Impact Adviser to the strategy, providing input and advice to help strengthen environmental, climate, and social outcomes related to the strategy’s conservation and restoration activities. Together, BTG Pactual TIG and Conservation International are advancing an approach that aims to conserve, restore, and reforest approximately 660,000 acres of degraded landscapes in Latin America. The approach blends commercial
Qatar Implements Relief Measures to Support Business Community28.4.2026 17:56:00 EEST | Press release
Qatar has activated a comprehensive package of support measures designed to maintain market stability and reinforce investor confidence amid evolving regional conditions. These measures, delivered through the nation’s foreign direct investment ecosystem, provide immediate financial, regulatory and operational relief to Qatar’s international business community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428904909/en/ Infographic highlights key relief measures implemented in Qatar to support the business community (Infographic: AETOSWire) H.E. Sheikh Faisal bin Thani Al Thani, Minister of Commerce and Industry and Chairman of Invest Qatar, stated: “Qatar’s commitment to its business community is unwavering. As regional conditions continue to evolve, we remain fully focused on acting decisively to support companies operating in our market, safeguard business continuity and reinforce confidence. Our approach is grounded i
Dubai’s Medcare Hospital Becomes the World’s First to Treat an Adult Spinal Muscular Atrophy (SMA) Patient Outside the US28.4.2026 16:57:00 EEST | Press release
Medcare Royal Speciality Hospital (MRSH) in Dubai has become the world’s first hospital outside the USA, to offer a newly licensed intrathecal gene therapy - Itvisma, to adult patients with Spinal Muscular Atrophy (SMA). This one-time treatment was recently administered to a 22-year-old Egyptian patient, who was diagnosed at 18 months and confined to a wheelchair for most of his life. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428038416/en/ Dr. Vivek Mundada with Medcare multidisciplinary medical team (Photo: AETOSWire) Last year, Medcare also became the first healthcare provider globally to administer the newly licensed Itvisma to a four-year-old international SMA patient. SMA is a rare neuromuscular disease that leads to progressive muscle weakness and loss of mobility, impacting movement, breathing, and swallowing. Until now, advancements in gene therapy for SMA were primarily restricted to children under the age o
Perpetual Atomics and QSA Global Fuel the World’s First Americium-Powered Radioisotope Heater Unit Core28.4.2026 16:48:00 EEST | Press release
In a landmark achievement for international space exploration, Perpetual Atomics, QSA Global, Inc. and the University of Leicester have completed the first historical production of an Americium-fuelled Radioisotope Heater Unit (RHU) full scale core containing ceramic form americium-241 pellets in a metal containment structure. This breakthrough builds on the successful americium pelleting work in late 2025 and on two decades of experience in leading the development of americium space nuclear power systems by the Leicester team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428027123/en/ QSA Global and Perpetual Atomics Team Born out of ENDURE, a European Space Agency (ESA) project, and part of a transatlantic collaboration, this achievement provides the steppingstones for an industrial pathway to deliver radioisotope power systems for spacecraft enabling these to survive and thrive in the most extreme environments in the
Alipay Launches AI Payment Processing Product to Help Businesses and OPCs Thrive in the Agentic Economy28.4.2026 16:47:00 EEST | Press release
Alipay today launched a new AI payment processing product that enables businesses, large and small, including One Person Companies (OPCs) in the Chinese mainland, to receive payments seamlessly when autonomous AI agents, including OpenClaw-type agents, purchase their services. This new product is being launched as AI agents are increasingly executing tasks on behalf of users, from booking travel and comparing prices, to allocating computing power and buying tokens. The product is available on Alipay’s website (https://aipay.alipay.com/). With Alipay’s AI payment processing product, small and medium-sized businesses do not need to build complex payment or settlement systems. By simply onboarding their monetizable services, businesses can reach more customers and receive payment each time an AI agent purchases their service. Bocha, an AI-powered search tool offering web search support for AI applications including DeepSeek, has already adopted Alipay’s AI payment processing product, tran
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