Princeton, NJ and TOKYO, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that results of the Phase 3 ROCKET-SHUTTLE trial of rocatinlimab, an investigational T-cell rebalancing therapy, will be presented as a late breaking oral presentation at the European Academy of Dermatology and Venerology (EADV) 2025 Annual Meeting to be held in Paris, France from September 17-20, 2025. This trial assessed the efficacy and safety of rocatinlimab every 4 weeks in combination with topical corticosteroids and/or topical calcineurin inhibitors in adults with moderate-to-severe atopic dermatitis (AD).

Moderate-to-severe AD is a chronic inflammatory skin disease that can cause severe itching and pain. Despite available treatment options, there remains a significant unmet need as some patients with moderate to severe AD fail to achieve or sustain treatment goals. 

Title: Rocatinlimab with Concomitant Topical Therapy Significantly Improved Clinical Signs and Symptoms of Atopic Dermatitis in Adults: Results from the Phase 3 ROCKET-SHUTTLE Trial

Presenter: Eric Simpson, MD, MCR
Date: Thursday, Sept. 18th
Time: 15:00-15:15 CEST
Location: Paris Convention Centre, Paris NORD

About the ROCKET Phase 3 Program
ROCKET is a comprehensive, global Phase 3 clinical trial program comprised of eight studies intended to establish the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD) as well as multiple dosing regimens.

About Moderate to Severe Atopic Dermatitis
Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful. People with moderate to severe atopic dermatitis experience chronic symptoms, intensified by unpredictable flare-ups that can be painful and disruptive to everyday life. More than half of these patients report severe itching, leading to repeated scratching which can cause the skin to thicken and become vulnerable to infection. Atopic dermatitis (all severities) affects 15-20% of children and up to 10% of adults. T-cell imbalance is a root cause of atopic dermatitis, contributing to clinical manifestations including the disease's recurring, unpredictable symptoms.

About Rocatinlimab
Rocatinlimab is an anti-OX40 monoclonal antibody being investigated for the treatment of moderate to severe atopic dermatitis. Rocatinlimab has the potential to be the first and only T-cell rebalancing therapy that inhibits and reduces pathogenic effector and memory T cells by targeting the OX40 receptor. OX40 is a receptor on activated T cells, which are key drivers of systemic and local inflammatory responses in atopic dermatitis and other conditions. It has been reported that effector and memory T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in disease heterogeneity and chronicity.

Rocatinlimab is also being studied for moderate to severe uncontrolled asthma, prurigo nodularis and potentially other conditions where T-cell imbalance is a root cause of inflammation. The initial antibody was discovered in collaboration between Kyowa Kirin and La Jolla Institute for Immunology.

Rocatinlimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by the U.S. FDA or any other regulatory authority.

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 leads the development, manufacturing, and commercialization for rocatinlimab for all markets globally, except Japan, where Kyowa Kirin retains 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 and deliver novel medicines and treatments 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 with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com.

Hiroki Nakamura: Japan
Corporate Communications Department, Kyowa Kirin
media@kyowakirin.com

Subrenie Thomas-Smith: North America
R&D Patient Advocacy and Engagement, Kyowa Kirin
subrenie.thomas-smith.8c@kyowakirin.com