Kyowa Kirin Announces Late-Breaking Abstract Presentation at the American Academy of Dermatology Annual Meeting 2025

Rhea-AI Summary

Kyowa Kirin (TSE: 4151) announced that results from their Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy for moderate-to-severe atopic dermatitis (AD), will be presented at the American Academy of Dermatology Annual Meeting 2025 in Orlando.

The ROCKET HORIZON trial is a Phase 3, randomized, placebo-controlled study involving 726 adult patients. Participants received either rocatinlimab or placebo via subcutaneous injection every four weeks for 24 weeks, with a loading dose at week two. The trial's co-primary endpoints focus on achieving specific scores in the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) and Eczema Area and Severity Index (EASI-75) at week 24.

Rocatinlimab targets the OX40 receptor (OX40R), addressing T-cell imbalance, a root cause of inflammatory diseases including AD. The ROCKET Phase 3 program comprises eight studies evaluating rocatinlimab's safety and efficacy across multiple dosing regimens in adults and adolescents with moderate to severe AD.

Positive

• Large-scale Phase 3 trial with 726 patients demonstrates development progress
• Comprehensive clinical program with 8 studies shows robust development strategy

Negative

• None.

PRINCETON, N.J., Feb. 26, 2025 /PRNewswire/ -- 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 aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, Kyowa Kirin has invested in drug discovery and biotechnology innovation for more than 70 years and is 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/hematology and rare diseases. A shared commitment to Kyowa Kirin's values, to sustainable growth, and to making people smile unites Kyowa Kirin across the globe. Kyowa Kirin Canada, Inc., is a wholly owned subsidiary of Kyowa Kirin, Inc., and part of the North American operations of Kyowa Kirin Co., Ltd. You can learn more about the business of Kyowa Kirin at www.kyowakirin.com, and about Kyowa Kirin Canada at: Kyowa Kirin Canada | Kyowa Kirin North America.

 

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SOURCE Kyowa Kirin

FAQ

What are the primary endpoints of KYKOY's ROCKET HORIZON Phase 3 trial for rocatinlimab?

The trial has two co-primary endpoints: achieving vIGA-AD score of 0 or 1 with ≥2-point reduction from baseline, and achieving ≥75% reduction in EASI-75 score, both measured at week 24.

How many patients are enrolled in KYKOY's ROCKET HORIZON Phase 3 trial?

The trial includes 726 adult patients with moderate to severe atopic dermatitis.

What is the dosing schedule for rocatinlimab in KYKOY's Phase 3 trial?

Patients receive subcutaneous injections every four weeks for 24 weeks, with an initial loading dose at week two.

How many studies are included in KYKOY's ROCKET Phase 3 program for rocatinlimab?

The ROCKET Phase 3 program comprises eight studies evaluating rocatinlimab's safety and efficacy across multiple dosing regimens.