Kyowa Kirin Announces Symposium, Acceptance of Abstract for Presentation at American Academy of Dermatology 2024 Meeting

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Princeton, NJ and TOKYO, February 14, 2024 – Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that disease education and data from the Phase 2b study of rocatinlimab (AMG451/KHK4083), an investigational product being studied in patients with moderate-to-severe atopic dermatitis, will be presented at the upcoming American Academy of Dermatology (AAD) 2024 Annual Meeting in San Diego from March 8-12, 2024.

Atopic Dermatitis (AD), a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, is driven by skin barrier disruption and T cell–dependent inflammatory pathways; the relative contribution of different inflammatory pathways in driving disease can vary across populations and within individuals over time.

Globally, the prevalence of AD is up to 10% among adults and up to 20% among children, making it the 15th most common non-fatal disease and the skin disorder with the highest disease burden, in terms of disability-adjusted life-years.

Despite available therapies, many patients with moderate-to-severe AD fail to achieve or sustain treatment goals and/or may not be suitable for or tolerate these therapies. Thus, there remains a need for therapeutic options that can deliver durable benefits across a heterogeneous AD patient population.

AD is associated with a significant clinical burden due to unpredictable flares (acute worsening of symptoms) and chronic symptoms, including redness, dryness, and lichenification (skin thickening); clinical burden may be more prominent for those with moderate-to-severe disease. Drs Chih-ho Hong and Raj Chovatiya will highlight data on the heterogeneity of atopic dermatitis and the role of T cells and OX40 signaling in disease pathogenesis.

Symposium: From Heterogeneity Comes New Insights: Exploring the role of T Cells and OX40 in Atopic Dermatitis
Presenters: Chih-ho Hong, MD, Clinical Assistant Professor, University of British Columbia
          Raj Chovatiya, MD, PhD, Assistant Professor of Dermatology, Northwestern University Feinberg School of Medicine in Chicago, Illinois
Date: Saturday, March 9
Time: 11:30 am – 12:15 pm PST
Location: Exhibit Hall, Theater 2

e-Poster Title: Rocatinlimab Significantly Improves Clinical Responses in Patients with Moderate-To-Severe Atopic Dermatitis by Week 2 in a Randomized Double-Blind Placebo-Controlled Phase 2b Study
Author: Emma Guttman- Yassky, MD, PhD
Date: Friday, March 8

About rocatinlimab

Rocatinlimab (AMG 451/KHK4083), an investigational product, is a potential first-in-class anti-OX40 monoclonal antibody that is being studied for its ability to inhibit and reduce the number of OX40+ pathogenic T cells responsible for driving systemic and local AD inflammatory responses. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. The initial antibody was discovered in collaboration between Kyowa Kirin US Research and La Jolla Institute for Immunology.

Amgen and Kyowa Kirin Collaboration

On June 1, 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. 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-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia.

About Kyowa Kirin

Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by severe and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International. You can learn more about the business of Kyowa Kirin at: www.kyowakirin.com.

CONTACT:

Hiroki Nakamura: Global and Japan
Corporate Communications Department
Tel: +81-3-5205-7205
media@kyowakirin.com

Lauren Walrath: North America
Vice President, Public Affairs – North America
Tel: +01-646-526-4454
lauren.walrath.g4@kyowakirin.com

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