Kyowa Kirin Co., Ltd. · TSE:4151
Kyowa Kirin — Inflammatory Skin Disease Summit (ISDS) 2021
18 slides from Kyowa Kirin's conference presentation, Nov 5, 2021
Slide 1: Update on KHK4083
Update on KHK4083 Inflammatory Skin Disease Summit (ISDS) 2021 Presentation November 5, 2021
Slide 2: Forward-looking statements disclaimer
This document contains certain forward-looking statements relating to such items as the company’s (including its domestic and overseas subsidiaries) forecasts, targets and plans. These forward-looking statements are based upon information available to the company at the present time and upon reasona
Slide 3: Treatment with KHK4083/AMG 451 induces durable modulation of AD-related biomarkers
ISDS 2021 Treatment with KHK4083/AMG 451, an antagonist of OX40, induces durable modulation of atopic dermatitis (AD)-related blood/skin biomarkers Emma Guttman-Yassky,1 Munetake Shimabe,2 Rui Ohashi,3 Takeshi Matsui,2 Ehsanollah Esfandiari,3,4 Etsuji Kaneko2 1Icahn School of Medicine at Mount Sinai
Slide 4: KHK4083/AMG targets OX40 as a potential novel target for AD treatment
ISDS 2021 KHK4083/AMG 451 targets OX40 as a potential novel target for AD treatment The OX40–OX40L axis plays a critical role in long-lasting T-cell Naïve T cells TCR MHC I CD28 responses B7 Activated APC OX40 is expressed by activated T cells after antigen recognition and Primed T cell binds OX
Slide 5: Objectives
ISDS 2021 Objectives In a randomized, double-blind, placebo-controlled phase 2b study, we assessed the efficacy and safety of 4 dose regimens of KHK4083/AMG 451 in patients with moderate-to-severe AD We also monitored AD-related biomarkers (in blood) and target engagement biomarkers (in blood an
Slide 6: Phase 2b Study Design (NCT03703102)
ISDS 2021 Phase 2 Study Design (NCT03703102) Treatment A Treatment B Primary efficacy endpoint Screening Follow-up • % change in EASI score from BL to W16 (Up to Week 18) (Week 18-Week 36) Secondary efficacy endpoints Adults with • Reduction of ≥50%, ≥75%, and ≥90% in Placebo KHK4083 600 mg SC Q2W E
Slide 7: Baseline Demographics and Disease Characteristics
ISDS 2021 Baseline Demographics and Disease Characteristics (Safety Analysis Set) All baseline parameters were generally well-balanced among the treatment groups Placebo/ KHK4083 KHK4083 KHK4083 KHK4083 KHK4083 150 mg 600 mg 300 mg 600 mg 600 mg Q4W Q4W Q2W Q2W Q2W Total Characteristics N=54 N=53 N=
Slide 8: Proportion of Patients Who Achieved EASI-75
Proportion of Patients Who Achieved EASI-75 ISDS 2021 (Non-responder Imputation, Full Analysis Set) Proportions of EASI-75 responders at Week 16 were significantly higher in all KHK4083-treated cohorts versus placebo Treatment A Treatment B (Placebo-controlled period) (All groups received KHK4083) W
Slide 9: Durability of EASI-75 Response After Treatment Discontinuation
Durability of EASI-75 Response After Treatment Discontinuation ISDS 2021 The KM curve censored in Subjects who Achieved EASI-75 at Week 36 37 (26%) EASI 75 responders who received rescue therapy EASI-75 response was durable even after discontinuation of KHK4083 at Week 36 during off-treatment 100 80
Slide 10: TEAEs – Treatment A
ISDS 2021 TEAEs – Treatment A (Safety Analysis Set) In Treatment A, 81% TEAEs occurred in KHK4083 groups versus 72% in the placebo group KHK4083 KHK4083 KHK4083 KHK4083 KHK4083 150 mg 600 mg 300 mg 600 mg Placebo Category Total Q4W Q4W Q2W Q2W N=57 N=216 N=54 N=53 N=55 N=54 Any TEAEs 37 (68.5) 45 (8
Slide 11: TARC: Median % Change From Baseline
TARC: Median % Change From Baseline at Each Scheduled Visit ISDS 2021 (Safety Analysis Set) TARC levels clearly reduced in all KHK4083 groups. In the placebo/KHK4083 600 mg Q2W group, TARC reached almost the same levels as those in other KHK4083 groups around Week 32. TARC reduction was near maximum
Slide 12: IgE: Median % Change From Baseline
ISDS 2021 IgE: Median % Change From Baseline at Each Scheduled Visit (Safety Analysis Set) Total IgE was continuously reduced after Week 16 in KHK4083 groups and reached 50% reduction This trend continued during off-treatment after Week 36 except in the KHK4083 150 mg Q4W group Follow-up Treatment A
Slide 13: IL-22: Median % Change From Baseline
ISDS 2021 IL-22: Median % Change From Baseline at Each Scheduled Visit (Safety Analysis Set) IL-22 reduction was confirmed at Week 16 in all KHK4083 groups and continued after Week 16 The reduction was maintained during off-treatment after Week 36 Follow-up Treatment A Treatment B (After KHK4083 (Pl
Slide 14: Total OX40+ Helper T Cells in Peripheral Blood
Total OX40+ Helper T Cells in Peripheral Blood: Median % Change From Baseline at ISDS 2021 Each Scheduled Visit (Clinical Biomarker Statistical Analysis Set) KHK4083 quickly showed reduction in OX40+ helper T cells in all KHK4083 groups This reduction persisted during off-treatment after Week 36 Fol
Slide 15: Unoccupied OX40+ Helper T Cells in Peripheral Blood
Unoccupied OX40+ Helper T Cells in Peripheral Blood: Median % Change From ISDS 2021 Baseline at Each Scheduled Visit (Clinical Biomarker Statistical Analysis Set) Unoccupied OX40+ helper T cells were detected at very low levels from Week 1 in all KHK4083 groups and retained at least 10 weeks after t
Slide 16: OX40+ Cells in the Upper Dermis
OX40+ Cells in the Upper Dermis (Skin Biopsy Lesion): Median % Change From ISDS 2021 Baseline at Each Scheduled Visit (Clinical Biomarker Statistical Analysis Set) OX40+ cells were removed from the upper dermis Faster reduction of OX40+ cells was observed in the 300 mg Q2W and 600 mg Q4W groups Remo
Slide 17: Conclusions
ISDS 2021 Conclusions In patients with moderate-to-severe AD KHK4083/AMG 451 groups demonstrated significant improvements in efficacy parameters, compared with the placebo group, at Week 16 and beyond KHK4083/AMG 451 induced significant modulation of AD-related biomarkers, including reduction in
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