Kyowa Kirin Announces Acceptance for Presentation of Two Posters at the American Academy of Dermatology Annual Meeting 2023

Rhea-AI Summary

Kyowa Kirin Co., Ltd. announced the presentation of data from its Phase 2b study of rocatinlimab at the American Academy of Dermatology 2023 Annual Meeting on March 17-21 in New Orleans. Rocatinlimab, an investigational anti-OX40 monoclonal antibody, aims to treat moderate-to-severe atopic dermatitis, which affects approximately 15-20% of children and 10% of adults globally. Two posters will be presented, focusing on its efficacy and the reduction of IgE concentrations. Kyowa Kirin has partnered with Amgen for the development and commercialization of rocatinlimab globally, except in Japan, where it retains rights.

Positive

• Data from Phase 2b study of rocatinlimab to be presented at AAD 2023, indicating ongoing development progress.
• Potential first-in-class treatment for moderate-to-severe atopic dermatitis with significant clinical efficacy.

Negative

• None.

TOKYO, March 7, 2023 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that data from the Phase 2b study of rocatinlimab (AMG 451/KHK4083), an investigational product in patients with moderate-to-severe atopic dermatitis, will be presented at the upcoming American Academy of Dermatology (AAD) 2023 Annual Meeting to be held in New Orleans from March 17-21, 2023.

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.

Often beginning in childhood, AD affects 15-20% of children and up to 10% of adults, making it the 15th most common nonfatal disease. AD is prevalent in countries globally, with approximately 1 in 3 people with AD worldwide classifying their disease as moderate-to-severe. While there are available therapies there remains a need for a novel, highly efficacious, well-tolerated therapeutic option that can deliver durable benefits across a heterogeneous AD patient population.

Poster Title: Rocatinlimab demonstrates a significant reduction in IgE concentrations in addition to clinical efficacy measures in patients with moderate–severe atopic dermatitis (msAD) in a randomised, double-blind, placebo-controlled Phase 2 trial

Author: Emma Guttman-Yassky, MD, PhD., Camilla Chong, MD, DipPM, MFPM,
             Ehsanollah Esfandiari, MD, PhD.
Date: Friday, March 17^th 2:55 PM CDT
Location: Ernest N. Morial Convention Center (Level 1, Hall E, Poster Center 2)

Poster Title: Rocatinlimab demonstrates improvements in patient-reported outcomes in adult patients with moderate–severe atopic dermatitis in a Phase 2 trial

Author: Eric Simpson, MD, MCR, Angela Williams, PhD., Camilla Chong, MD, DipPM, MFPM,
             Ehsanollah Esfandiari, MD, PhD.
Date: Friday, March 17^th 2:05 PM CDT
Location:- Ernest N. Morial Convention Center (Level 1, Hall E, Poster Center 2)

About rocatinlimab

Rocatinlimab (AMG 451/KHK4083) an investigational product is a potential first-in-class anti-OX40 monoclonal antibody that inhibits and reduces 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 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 the business of Kyowa Kirin at: https://www.kyowakirin.com/.

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SOURCE Kyowa Kirin

FAQ

What is the significance of the Phase 2b study data presentation for KNBWY and KYKOY?

The Phase 2b study data presentation for rocatinlimab at the AAD 2023 indicates the progression of its development, reflecting positively on KNBWY and KYKOY's growth potential.

When and where will Kyowa Kirin present data on rocatinlimab?

Kyowa Kirin will present data on rocatinlimab at the American Academy of Dermatology Annual Meeting from March 17-21, 2023, in New Orleans.

What is rocatinlimab and its importance for KNBWY and KYKOY?

Rocatinlimab is an investigational anti-OX40 monoclonal antibody aimed at treating moderate-to-severe atopic dermatitis, representing a key asset for Kyowa Kirin's pipeline.

What collaboration exists between Kyowa Kirin and Amgen regarding rocatinlimab?

Kyowa Kirin and Amgen entered a collaboration to develop and commercialize rocatinlimab, with Amgen leading the development globally, excluding Japan.