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
IFF Declares Dividend for Third Quarter 202628.7.2026 23:15:00 EEST | Press release
IFF (NYSE: IFF) announced that its Board of Directors has declared a regular quarterly cash dividend of $0.40 per share of its common stock, payable on October 9, 2026 to shareholders of record as of September 18, 2026. Welcome to IFF At IFF (NYSE: IFF), we make joy through science, creativity and heart. As the global leader in flavors, fragrances, and health and biosciences, we deliver groundbreaking, sustainable innovations that elevate everyday products—advancing wellness, delighting the senses and enhancing the human experience.Learn more at iff.com, LinkedIn, Instagram and Facebook. © 2026 by International Flavors & Fragrances Inc. IFF is a Registered Trademark. All Rights Reserved. View source version on businesswire.com: https://www.businesswire.com/news/home/20260728319763/en/
Logitech Announces Q1 Fiscal Year 2027 Results28.7.2026 23:06:00 EEST | Press release
SIX Swiss Exchange Ad hoc announcement pursuant to Art. 53 LR — Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the first quarter of Fiscal Year 2027. Sales were $1.23 billion, up 7 percent in US dollars and 5 percent in constant currency, compared to Q1 of the prior year. GAAP gross margin was 49.5 percent, up 780 basis points, compared to Q1 of the prior year. Non-GAAP gross margin was 49.8 percent, up 770 basis points, compared to Q1 of the prior year. These numbers include $61 million in tariff refunds. GAAP operating income was $259 million, up 60 percent, compared to Q1 of the prior year. Non-GAAP operating income was $290 million, up 44 percent, compared to Q1 of the prior year. These numbers include $61 million in tariff refunds. GAAP earnings per share (EPS) was $1.63, up 66 percent compared to Q1 of the prior year. Non-GAAP EPS was $1.85, up 47 percent compared to Q1 of the prior year. Cash flow from operations was $167 million. The qua
Nexo Reaffirms EU Compliance28.7.2026 17:00:00 EEST | Press release
Nexo, a leading digital assets wealth platform, today reaffirmed product compliance across the European Economic Area (EEA), achieved ahead of MiCAR’s entry into force. The company operates with a local setup through two MiCAR-licensed partners bringing technical depth and operational maturity to Nexo's client-facing platform in the region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260728038475/en/ Nexo's setup pairs its global wealth platform with dedicated, licensed European infrastructure — splitting custody and brokerage across two regulated partners: Tangany, licensed under MiCAR, provides institutional-grade custody infrastructure for digital assets. Meanwhile, DLT Finance, licensed under MiCAR and authorized under MiFID II, provides brokerage infrastructure for digital assets and financial instruments. Together, these partnerships pair Nexo’s global wealth platform with infrastructure specifically built for Europ
Interactive Brokers Opens AI Connectivity to Any Tool Built on the MCP Standard28.7.2026 17:00:00 EEST | Press release
Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced that clients can now connect their accounts to nearly any AI tool they already use. Previously limited to the certified marketplaces for ChatGPT, Claude, and Grok, clients can now also connect from a growing range of tools that support the Model Context Protocol (MCP), including Claude Code, Cursor, Perplexity, and Windsurf. MCP has become the common standard for connecting AI applications to outside services. Interactive Brokers' AI Integration has been built on MCP since launch, and clients can now connect from any MCP-compatible tool in addition to the certified marketplaces. “Interactive Brokers has long offered open APIs that let clients connect their accounts to the tools and systems they choose,” said Milan Galik, Chief Executive Officer of Interactive Brokers. “Supporting AI tools built on the Model Context Protocol (MCP) is a natural extension of that philosophy. It gives clients the flexibility to
Estée Lauder Announces New Fragrance, Glimmer, with Global Campaign Starring Hailee Steinfeld28.7.2026 17:00:00 EEST | Press release
Today, Estée Lauder announces the launch of Glimmer, a new prestige fragrance created for a new generation of consumers. An amber floral fragrance with a gourmand twist, Glimmer transforms the power of everyday "glimmers” - small moments of joy, hope, and connection - into a sensorial fragrance experience designed to inspire optimism, foster community, and leave a lasting impression. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727469772/en/ Hailee Steinfeld stars as the face of Glimmer Acclaimed actress and singer Hailee Steinfeld stars as the face of Glimmer. Rooted in the belief that one spark can ignite many, the campaign positions Hailee and her singing voice as catalysts for the joy, optimism, and connection that are at the heart of Glimmer. “Hailee is the embodiment of what Glimmer represents; she is confident, has a contagious sense of joy, and understands the power of connecting with her community,” said Justin
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