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
SES Announces Extraordinary General Meeting of Shareholders15.5.2026 09:30:00 EEST | Press release
SES: Société Anonyme RCS Luxembourg B 81267 Notice is hereby given of the Extraordinary General Meeting of SES, Société Anonyme, to be held at the Company's registered office at Château de Betzdorf, L-6815 Betzdorf (the "Company"), Luxembourg, on Wednesday 17 June 2026 at 3:00 p.m. CET AGENDA Attendance list, quorum and adoption of the agenda Nomination of a secretary and of two scrutineers Cancellation of shares purchased in connection with the buy-back programme of 2 November 2023, as amended on 2 May 2024, in accordance therewith and pursuant thereto - Reduction of the share capital in accordance with article 450-5 of the law of 10 August 1915 on commercial companies, as amended, by forty-four million nine hundred ten thousand seven hundred eighty euro (EUR 44,910,780) through the cancellation of thirty-five million nine hundred and twenty-eight thousand six hundred and twenty-four (35,928,624) shares divided into (i) twenty-three million nine hundred and fifty-two thousand four hun
Experian Partners With ServiceNow to Scale Trusted Decisioning to Agentic AI15.5.2026 09:00:00 EEST | Press release
Experian, the global data and technology company, and ServiceNow (NYSE: NOW), the AI control tower for business reinvention, today unveil a new global multi-year partnership which harnesses the power of autonomous AI agents across platforms, helping businesses make faster and smarter decisions at scale. Through this partnership, autonomous AI agents can gain the ability to act faster, and more consistently, starting with employee onboarding, third-party risk management and model life cycle governance use cases. A major challenge for global organisations adopting agentic AI is achieving scale, with deployments often constrained by a lack of trusted data. In fact, industry research shows that data limitations are the primary barrier for eight in ten organisations. By connecting trusted intelligence directly into enterprise workflows, this partnership enables agentic AI to scale well beyond pilot deployments. With the Experian Ascend Platform natively connected to the ServiceNow AI Platfo
Meiji Seika Pharma: Positive Results from the Phase III Integral-1 Trial of Nacubactam, a Novel β-Lactamase Inhibitor, in Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis ― Published in The Lancet15.5.2026 04:00:00 EEST | Press release
Meiji Seika Pharma Co., Ltd. (headquartered in Tokyo; President and Representative Director: Toshiaki Nagasato) today announced that the results of the Integral-1 study, one of two global Phase III clinical trials evaluating the efficacy and safety of its novel β-lactamase inhibitor nacubactam (development code: OP0595), have been published in The Lancet. The article is entitled “---Efficacy and safety of cefepime–nacubactam and aztreonam–nacubactam compared with imipenem–cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial” (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00596-9/fulltext) Integral-1 is a global, double-blind, randomized Phase III trial (jRCT2031230075) in patients with complicated urinary tract infection or acute uncomplicated pyelonephritis that compared the efficacy and safety of nacubactam co-administered with either cefepime or aztreonam versus imipenem-c
Xsolla and Skich Announce Strategic Partnership to Bring Merchant of Record Payments to an Alternative Mobile Game Marketplace14.5.2026 19:00:00 EEST | Press release
Xsolla, a leading global video game commerce company, today announced a strategic partnership with Skich, an alternative mobile game marketplace operating on iOS in the EU under Apple's Digital Markets Act provisions and on Android globally. Under the agreement, Xsolla will serve as Merchant of Record for in-app purchases and paid game sales distributed through the Skich Store. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514867730/en/ Graphic: Xsolla Skich serves as an alternative to traditional mobile storefronts, offering developers a way to reach players outside platform-controlled distribution channels. The partnership with Xsolla enables Skich to offer a fully compliant payment and commerce layer, with Xsolla managing payment processing, tax collection, refunds, and regulatory compliance on behalf of developers, removing a significant operational and legal barrier for studios looking to distribute through alternat
Boomi Teams up With Gong to Bring Revenue AI to Boomi Agentstudio14.5.2026 19:00:00 EEST | Press release
Boomi, the data activation company for AI, today announced a collaboration withGong, the leader in Revenue AI, to bring revenue signals captured in Gong natively into the Boomi Enterprise Platform. This collaboration enables enterprises to establish an active data foundation designed to transform customer conversations into coordinated, automated actions across systems and functions enterprise-wide with Boomi Agentstudio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260514443012/en/ Boomi Teams Up with Gong to Bring Revenue AI to Boomi Agentstudio Gong goes beyond capturing deal activity to surface real-time insights into risk, buyer intent, competitive dynamics, and key engagement signals. That intelligence moves from conversation to coordinated action, flowing across CRM, ERP, product, and operational systems with the governance and security that enterprises require. Through this collaboration, these signals can be serve
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