Princeton, New Jersey – February 26, 2025 – Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that results of the Phase 3 ROCKET HORIZON 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 American Academy of Dermatology (AAD) 2025 Annual Meeting to be held in Orlando, Florida from March 7-11, 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: Rocatinlimab Significantly Improved Clinical Signs and Symptoms by Targeting OX40R+ T cells in Patients with Moderate-to- Severe Atopic Dermatitis: Results from the Phase 3 ROCKET
HORIZON Trial
Presenter: Emma Guttman-Yassky, MD, PhD
Date: Saturday, March 8th Time: 1 - 4 pm EST
Location: Orange County Convention Center, Chapin Theater Level 2, Orlando, Fla.
ROCKET HORIZON and the ROCKET Phase 3 Program
ROCKET HORIZON is a Phase 3, randomized,
placebo-controlled, double-blind trial assessing the efficacy, safety and tolerability of rocatinlimab
monotherapy in adults with moderate to severe atopic dermatitis. The trial includes 726 adult patients who were
randomized to receive rocatinlimab or placebo administered through a subcutaneous injection every four weeks for
24 weeks with a loading dose at week two. Co-primary endpoints for the trial are achievement of a Validated
Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) with a ≥
2-point reduction from baseline at week 24 and achievement of ≥ 75% reduction from baseline in Eczema Area and
Severity Index score (EASI-75) at week 24. (In the US, a more stringent Investigator Global Assessment, revised
IGA (rIGA), replaces vIGA in the co-primary endpoint.) Key secondary endpoints included the impact of
rocatinlimab on itch as well as safety and tolerability. 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 AD across 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. Almost
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 receptor human monoclonal antibody being investigated for the treatment of
moderate-to-severe atopic dermatitis. Rocatinlimab is also being studied for moderate to severe uncontrolled
asthma and, prurigo nodularis. 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 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 Kyowa Kirin at: kyowakirin.com.
CONTACT:
Kyowa Kirin
Hiroki Nakamura: Japan
Corporate Communications Department media@kyowakirin.com
Lisa Popyk
Corporate Communications Senior Director, North America
Lisa.popyk.3z@kyowakirin.com
