Kyowa Kirin Will Present Phase 2b Post-hoc Analysis and Symposium at the American Academy of Dermatology Annual Meeting 2024

Princeton, NJ and TOKYO, March 8, 2024- Kyowa Kirin Co., Ltd. (TSE: 4151) today announces that post-hoc analysis data from the Phase 2b study of rocatinlimab (AMG 451/KHK4083), an investigational product currently being evaluated for the treatment of patients with moderate-tosevere atopic dermatitis (msAD), will be presented at the American Academy of Dermatology (AAD) 2024 Annual Meeting to be held in San Diego from March 8-12, 2024.
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.

Patients with msAD continue to need additional treatment options due to ongoing symptoms like pruritis and scratching. Thus, there remains a need for therapeutic options that can deliver benefits across a heterogeneous AD patient population.

A multicenter, randomized, double-blind, placebo-controlled Phase 2b trial (NCT03703102) evaluated rocatinlimab for msAD. Primary endpoint achievement (Week 16 Eczema Area and Severity Index [EASI]) has been presented. Randomized patients (1:1:1:1:1) received subcutaneous rocatinlimab 150mg/600mg every 4 weeks (Q4W) or 300mg/600mg every 2 weeks (Q2W) for 36 weeks, or placebo (Weeks 0–18) followed by rocatinlimab (600mg Q2W Weeks 18–36). All cohorts had 20-week off-treatment follow-up.

The current post-hoc analysis (267 patients; rocatinlimab: n=210, placebo: n=57) of the phase 2b study evaluated EASI and pNRS between baseline and week 16 to investigate early clinical response. Difference in least squares mean of percent change from baseline between rocatinlimab cohorts and placebo were assessed. The post hoc analysis showed statistically significant improvement in pNRS scores for patients in the treatment arms compared to placebo.

Pruritis improved with rocatinlimab by Week 2 in all cohorts (−18.40% to −21.96%; p≤0.018) except 600mg Q4W (−9.66%; p=0.208), and in all cohorts by Week 4 (−15.70% to −27.19%; p≤0.045); EASI improvements vs. placebo were significant in all rocatinlimab cohorts by Week 6 (−20.50% to −32.13%; p≤0.001), and the 300mg & 600mg Q2W cohorts by Week 2 (−13.27% and −13.66%; p≤0.028). Further improvements vs. placebo continued to Week 16; improvements vs. baseline continued in all active cohorts to Week 36 and were maintained for 20 weeks offtreatment.

Adverse events reported were generally similar between rocatinlimab groups. Common adverse events during the double-blind period included fever, chills, headache, aphthous ulcers and nausea.