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
Xsolla Launches Game Biz Institute, an Editorial Platform Where Industry Practitioners Explain the Business of Games27.8.2026 18:32:00 EEST | Press release
Xsolla, a global commerce company, today announced the launch of Game Biz Institute (GBI), an editorial platform where named industry practitioners and researchers examine the commercial layer of games: direct-to-player distribution, payments, monetization, user acquisition, and retention. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827362663/en/ Graphic: Xsolla Game design has a curriculum. The business of games does not. Engines, pipelines, production, and narrative are taught at hundreds of universities, while the commercial machinery that determines whether good work becomes a durable company is still learned through expensive trial and error, usually after the decisions that mattered have already been made. GBI was built to close that gap by publishing what practitioners have actually learned running these businesses. "Game developers have never had more data and less clarity," said Chris Hewish, President of Xsol
Star Wars Zero Company™ Now Available On PC, PlayStation 5 and XBOX Series Consoles27.8.2026 18:00:00 EEST | Press release
Electronic Arts Inc. and Bit Reactor, in collaboration with Lucasfilm Games, announced today that Star Wars Zero Company™, a single-player turn-based tactics game set in the twilight of the Clone Wars™, is now available for PC via the EA app, Steam, and Epic Games Store, and PlayStation®5 and XBOX Series consoles. In Star Wars Zero Company, former Republic officer Hawks and Zero Company, an elite squad of unconventional professionals for hire, are recruited for an operation by Republic Intelligence. From ex-nobles to ex-cons, they now share one mission: Stop the Infinite Coil, a Separatist-aligned cult, and their leader Kundri Fathom before the deadly Shadow Plague consumes the galaxy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827012810/en/ https://www.youtube.com/watch?si=7SYogg8ILAD3tUG3&v=AxAgeglgSeA&feature=youtu.be “After all these years of hard work from our amazing team, Star Wars Zero Company is a go for laun
Rehlko Joins Wisconsin Data Center Coalition as Newest Energy Resilience Member, Reinforcing Its Role at the Center of AI and Digital Infrastructure Growth27.8.2026 16:15:00 EEST | Press release
Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today announced it has joined the Wisconsin Data Center Coalition (WIDCC) as the organization's newest energy resilience member. The membership reflects Rehlko's commitment to advancing Wisconsin's role as a leader in responsible AI infrastructure development, built on reliable and scalable power. Rapid growth in hyperscale and enterprise data center investment is reshaping markets across the world, and Rehlko is building the power infrastructure that makes it possible. Sitting at the intersection of the structural forces driving AI infrastructure expansion, grid reliability, and accelerating electrification, Rehlko brings more than a century of engineering depth and lifecycle capability to the table. WIDCC brings together stakeholders from across Wisconsin's technology, utility, economic development, workforce development, govern
GenNx360 Capital Partners Closes Fourth Flagship Fund at $865 Million27.8.2026 15:30:00 EEST | Press release
GenNx360 Capital Partners (“GenNx360” or “the Firm”), a New York City-based private equity firm investing in U.S. lower middle market industrial services and business services companies, today announced the successful closing of GenNx360 Capital Partners IV, L.P. (“Fund IV” or “the Fund”), with $865 million in commitments, exceeding its target. Fund IV is the largest fund raised in GenNx360’s history. Fund IV was supported by a diverse group of existing and new investors including leading pensions, asset managers, insurance companies, foundations, and family offices, reflecting conviction in the firm’s disciplined investment approach, operational value creation model, and tenured, diverse team. Fund IV will continue GenNx360’s differentiated strategy of partnering with lower middle market founders and management teams to scale essential services businesses. Fund IV has made five investments to date across infrastructure services, testing and inspection services, aerospace and defense,
Alipay Ant Forest Turns 700 Million Users’ Daily Green Actions into 700 Million Trees Over a Decade of Technology-enabled Environmental Program27.8.2026 15:02:00 EEST | Press release
Alipay Ant Forest, Ant Group’s green initiative that encourages people to participate in environmental protection through simple, everyday low-carbon actions, today announced that more than 700 million users across China have joined the program as of August 2026. Together, they have helped support the planting of over 700 million trees, contributing to ecological restoration efforts in some of China’s most arid and environmentally fragile regions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260827995848/en/ Before (2019) and after (2026) comparison of Ant Forest Project No. 464 in Inner Mongolia. Launched in 2016 within the Alipay app, Ant Forest transforms individual environmental choices into collective climate action. When users make greener lifestyle choices, such as taking public transportation, cycling, paying bills online to avoid paper invoices, or choosing digital services, they earn virtual “green energy points”
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