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Kyowa Kirin Announces Abstract Presentation at the European Academy of Dermatology and Venereology (EADV) Congress

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Kyowa Kirin (OTC:KYKOY) announced that results from their Phase 3 ROCKET IGNITE trial of rocatinlimab will be presented at the EADV 2025 Annual Meeting in Paris. The investigational therapy targets the OX40 receptor in patients with moderate-to-severe atopic dermatitis.

The presentation will be delivered by Dr. Emma Guttman-Yassky on September 19th at 4:40 PM CEST. The study focuses on rocatinlimab's efficacy and safety in treating atopic dermatitis, a chronic inflammatory disease characterized by skin redness, pruritus, and pain.

Kyowa Kirin (OTC:KYKOY) ha annunciato che i risultati del loro trial di Fase 3 ROCKET IGNITE su rocatinlimab saranno presentati al Meeting Annuale EADV 2025 a Parigi. La terapia sperimentale è diretta al recettore OX40 nei pazienti con dermatite atopica da moderata a grave.

La presentazione sarà tenuta dalla Dott.ssa Emma Guttman-Yassky il 19 settembre alle 16:40 CEST. Lo studio si concentra sull’efficacia e la sicurezza di rocatinlimab nel trattamento della dermatite atopica, una malattia infiammatoria cronica caratterizzata da arrossamento cutaneo, prurito e dolore.

Kyowa Kirin (OTC:KYKOY) anunció que los resultados de su ensayo de Fase 3 ROCKET IGNITE con rocatinlimab serán presentados en la Reunión Anual EADV 2025 en París. La terapia en investigación se dirige al receptor OX40 en pacientes con dermatitis atópica de moderada a grave.

La presentación será realizada por la Dra. Emma Guttman-Yassky el 19 de septiembre a las 16:40 CEST. El estudio se centra en la eficacia y seguridad de rocatinlimab para tratar la dermatitis atópica, una enfermedad inflamatoria crónica caracterizada por enrojecimiento de la piel, prurito y dolor.

교와 키린 (OTC:KYKOY)은 로카틴리맙의 3상 ROCKET IGNITE 임상시험 결과가 2025년 파리에서 열리는 EADV 연례회의에서 발표될 것이라고 발표했습니다. 이 연구 중인 치료제는 중등도에서 중증 아토피 피부염 환자의 OX40 수용체를 표적으로 합니다.

발표는 엠마 굿만-야스키 박사가 9월 19일 오후 4시 40분(중앙유럽여름시간)에 진행할 예정입니다. 이 연구는 피부 발적, 가려움증, 통증이 특징인 만성 염증성 질환인 아토피 피부염 치료에서 로카틴리맙의 효능과 안전성에 초점을 맞추고 있습니다.

Kyowa Kirin (OTC:KYKOY) a annoncé que les résultats de leur essai de phase 3 ROCKET IGNITE sur le rocatinlimab seront présentés lors du Congrès annuel EADV 2025 à Paris. Ce traitement expérimental cible le récepteur OX40 chez des patients atteints de dermatite atopique modérée à sévère.

La présentation sera faite par la Dr Emma Guttman-Yassky le 19 septembre à 16h40 CEST. L’étude porte sur l’efficacité et la sécurité du rocatinlimab dans le traitement de la dermatite atopique, une maladie inflammatoire chronique caractérisée par des rougeurs cutanées, des démangeaisons et des douleurs.

Kyowa Kirin (OTC:KYKOY) gab bekannt, dass die Ergebnisse ihrer Phase-3-Studie ROCKET IGNITE mit Rocatinlimab auf dem EADV-Jahreskongress 2025 in Paris vorgestellt werden. Die experimentelle Therapie richtet sich gegen den OX40-Rezeptor bei Patienten mit mittelschwerer bis schwerer atopischer Dermatitis.

Die Präsentation wird von Dr. Emma Guttman-Yassky am 19. September um 16:40 Uhr MESZ gehalten. Die Studie untersucht die Wirksamkeit und Sicherheit von Rocatinlimab bei der Behandlung der atopischen Dermatitis, einer chronisch-entzündlichen Erkrankung, die durch Hautrötung, Juckreiz und Schmerzen gekennzeichnet ist.

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PRINCETON, N.J. and TOKYO, July 29, 2025 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that results of the Phase 3 ROCKET IGNITE trial of rocatinlimab, an investigational therapy targeting the OX40 receptor (OX40R) in patients with moderate-to-severe atopic dermatitis (AD), will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Annual Meeting to be held in Paris, France from September 17-20, 2025.

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. Expansion of OX40R+ pathogenic T cells leads to T-cell imbalance, a root cause of inflammatory diseases including AD.

Title: Efficacy & Safety of OX-40 Receptor Targeting with Rocatinlimab in Moderate-to-Severe Atopic Dermatitis: Results from the Phase 3 ROCKET-IGNITE Trial

Presenter: Emma Guttman-Yassky, MD, PhD

Date: Friday, September 19th
Time: 4:40 – 4:50 pm CEST
Session: FC 08 Atopic Dermatitis
Location: Paris Convention Centre, Pavillon 7.3, Room W05-W06

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 human 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 T cells by targeting the OX40 receptor. OX40 is a co-stimulatory receptor responsible for driving systemic and local inflammatory responses in atopic dermatitis and other conditions. 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.

Rocatinlimab is also being studied for prurigo nodularis, moderate to severe uncontrolled asthma 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.

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/.   

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.

CONTACT:

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

Subrenie Thomas-Smith: North America
Sr. Director, R&D Patient Engagement & Communications
subrenie.thomas-smith.8c@kyowakirin.com 

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SOURCE Kyowa Kirin

FAQ

When will Kyowa Kirin (KYKOY) present the Phase 3 ROCKET IGNITE trial results at EADV 2025?

Kyowa Kirin will present the results on Friday, September 19th, 2025 at 4:40 PM CEST at the Paris Convention Centre.

What is rocatinlimab and what condition does it treat?

Rocatinlimab is an investigational therapy targeting the OX40 receptor designed to treat moderate-to-severe atopic dermatitis, a chronic inflammatory skin condition.

Who will present Kyowa Kirin's ROCKET IGNITE trial results at EADV 2025?

Dr. Emma Guttman-Yassky, MD, PhD will present the trial results during the FC 08 Atopic Dermatitis session.

What is atopic dermatitis and how does it affect patients?

Atopic dermatitis is a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, driven by skin barrier disruption and T-cell-dependent inflammatory pathways.

Where will the EADV 2025 presentation take place?

The presentation will take place at the Paris Convention Centre, Pavillon 7.3, Room W05-W06 during the EADV 2025 Annual Meeting in Paris, France.
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