Kyowa Kirin Announces Three Abstracts and A Symposium at the European Academy of Dermatology and Venereology Congress 2023

TOKYO, Oct. 11, 2023 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that post-hoc analysis data from the Phase 2b study of rocatinlimab (AMG 451/KHK4083), an investigational product in patients with moderate-to-severe atopic dermatitis (AD), will be presented at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin, Germany in October 11-14, 2023.

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. Approximately 1 in 3 people living with AD worldwide are affected by moderate-to-severe disease. While several treatments are currently available, there remains a need for additional therapeutic options with a novel mechanism of action to treat across a heterogeneous AD patient population.

"We are pleased to share this additional data from the rocatinlimab Phase 2b study," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin. "It provides further insight into the potential of rocatinlimab in treating patients living with moderate-to-severe atopic dermatitis. Kyowa Kirin will continue our commitment to bring novel treatments and are advancing the development of rocatinlimab in several Phase 3 studies for atopic dermatitis in partnership with Amgen." The global Phase 3 ROCKET program, currently enrolling, recently surpassed 1,200 participants.

e-Poster Title: Rocatinlimab improves lichenification compared with placebo in adults with moderate-to-severe atopic dermatitis in a Phase 2b trial
Author: Kenji Kabashima, MD, PhD., Ehsanollah Esfandiari, MD, PhD., Hirotaka Mano, ME, Camilla Chong, MD, DipPM, MFPM, Emma Guttman-Yassky, MD, PhD.,
Date: October 11, 2023
Randomized patients (1:1:1:1:1) received subcutaneous rocatinlimab every 4 weeks (150 or 600 mg) or every 2 weeks (Q2W; 300 or 600 mg), or placebo for 18 weeks, followed by 18 weeks of rocatinlimab treatment (placebo group switched to 600 mg Q2W), with a subsequent 20-week off-treatment follow-up period (Weeks 36–56). EASI lichenification scores were assessed separately for the following body regions: head and neck (H&N), trunk, upper limbs, and lower limbs. Overall, 267 patients were randomized (rocatinlimab: n=210; placebo: n=57). At Week 16, treatment with rocatinlimab resulted in improvements in Eczema Area and Severity Index (EASI) lichenification scores across all body regions when compared with placebo. Lichenification improvements vs. placebo were statistically significant for all rocatinlimab treatment groups in the H&N region at Week 16. Improvements in EASI lichenification scores across all body regions continued up to Week 36 and were maintained during the off-treatment period, up to Week 56, in all rocatinlimab treatment groups. In patients who were switched from placebo to rocatinlimab treatment at Week 18, EASI lichenification scores improved from baseline across all body regions up to Week 36, and the improvements were maintained up to Week 56.

e-Poster Title: Rocatinlimab improves SCORAD compared with placebo in adults with moderate-to-severe atopic dermatitis regardless of baseline demographics in a Phase 2b trial
Author: Emma Guttman-Yassky, MD, PhD., Ehsanollah Esfandiari, MD, PhD., Hirotaka Mano, ME, Camilla Chong, MD, DipPM, MFPM, Kenji Kabashima, MD, PhD.
Date: October 11, 2023
Randomized patients (1:1:1:1:1) received subcutaneous rocatinlimab every 4 weeks (150 or 600 mg) or every 2 weeks (Q2W; 300 or 600 mg), or placebo for 18 weeks, followed by 18 weeks of rocatinlimab treatment (placebo switched to 600 mg Q2W) with a subsequent 20-week off-treatment follow-up period (Weeks 36–56). Overall, 267 patients were randomized (rocatinlimab: n=210; placebo: n=57). For the full analysis set at Week 16, the SCORing of Atopic Dermatitis (SCORAD) percentage changes from baseline for all rocatinlimab treatment groups were statistically significant vs. placebo (p<0.001 for all rocatinlimab groups). Furthermore, all baseline characteristic subgroup categories showed a similar pattern of reduction in SCORAD scores for all rocatinlimab treatment groups vs. placebo at Week 16 regardless of AD severity (by EASI and Investigator's Global Assessment (IGA) scores), duration of AD diagnosis, BMI, and age at baseline. Most subgroup categories achieved a statistically significant improvement compared with placebo, despite the smaller sizes of subgroup categories. SCORAD scores, consistent with EASI score (primary endpoint) and other endpoints, continued to improve in all subgroups across all rocatinlimab treatment groups through Week 36, and improvements were maintained in the off-treatment period up to Week 56. After 16 weeks of treatment, rocatinlimab improved SCORAD scores vs. placebo in adults with moderate-to-severe AD (msAD), regardless of their baseline characteristics for AD severity, duration of disease, BMI, and age.

e-Poster Title: Rocatinlimab improves SCORAD and DLQI in adults with moderate-to-severe atopic dermatitis and these effects were maintained in the 20-week off-treatment period in a double-blind randomized Phase 2b study
Author: Emma Guttman-Yassky, MD, PhD., Ehsanollah Esfandiari, MD, PhD, Camilla Chong, MD, DipPM, MFPM, Hirotaka Mano, ME, Kenji Kabashima, MD, PhD.
Date: October 11, 2023
Randomized patients (1:1:1:1:1) received subcutaneous rocatinlimab every 4 weeks (150 or 600 mg) or every 2 weeks (Q2W; 300 or 600 mg; rocatinlimab-rocatinlimab), or placebo for 18 weeks, followed by 18 weeks of rocatinlimab treatment (placebo switched to 600 mg Q2W; placebo-rocatinlimab) with a subsequent 20-week off-treatment follow-up period (Weeks 36–56). The full analysis set included 267 patients. Mean baseline scores ranged from 66.4–69.8 for SCORAD and 11.9–13.8 for Dermatology Life Quality Index (DLQI) among cohorts. At Week 16, percent change from baseline in SCORAD was significantly improved in all rocatinlimab cohorts vs. placebo (−41.04 to −55.83% vs. −19.99%, all p<0.001), as was DLQI (−38.28 to −50.42% vs. −5.28%; all p<0.02). SCORAD and DLQI improvements from baseline continued to Week 36 (−60.42 to −72.32% and −46.51 to −67.81%, respectively for all rocatinlimab-rocatinlimab cohorts) and were maintained during the 20-week off-treatment period until Week 56 (−59.76 to −69.23%; −47.76 to −60.76%, respectively). For the placebo-rocatinlimab cohort, after switching to active treatment from Week 18, SCORAD and DLQI were comparable to rocatinlimab-rocatinlimab cohorts by Week 36 (−57.47% and −51.41%, respectively) and were maintained during the off-treatment period (−67.42% and −58.43%, respectively). Consistent with significant EASI improvement, rocatinlimab demonstrated significant SCORAD and DLQI improvements, which were maintained for 20 weeks off-treatment.

Adverse events with an incidence of ≥ 5% in all rocatinlimab groups combined and more frequently reported than in the placebo group included pyrexia, chills, headache, aphthous ulcer, and nausea. TEAEs (Treatment emergent adverse events) of pyrexia and chills were mild to moderate in intensity and were mostly observed only after the first administration of rocatinlimab without resulting treatment discontinuation. There were no hypersensitivity reactions or deaths.

An Amgen & Kyowa Kirin co-sponsored symposium:
The Future of Atopic Dermatitis treatment with OX40 signaling will be presented by Andreas Wollenberg, MD, Dr Med, Dr HC, Melinda Gooderham, MD, MSc, FRCPC and Richard B. Warren, PhD, FRCP
Date: October 11th from 1-2 PM
Location: CET Hall A4

About rocatinlimab
Rocatinlimab (AMG 451/KHK4083), an investigational product, is a potential first-in-class anti-OX40 monoclonal antibody that is being studied for its ability to inhibit and reduce 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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