Expert Interview
Evaluating Phase 3 SHORE and COAST trial results for amlitelimab in moderate-to-severe atopic dermatitis
Ticker(s): SNYA dermatologist or immunologist with expertise in moderate-to-severe atopic dermatitis and biologic therapies. The expert should be familiar with global Phase 3 trial design, regional regulatory endpoints (US vs EU estimands), immune-modulating mechanisms such as OX40/OX40L signaling, and long-term treatment considerations including durability, safety, and dosing convenience.
SHORE met all primary and key secondary endpoints across both US and EU estimands, while COAST 2 showed statistical significance primarily in the US estimand. How should clinicians interpret the overall consistency of amlitelimab’s efficacy across these Phase 3 studies?
Added By: slingshot_insightsBoth SHORE and COAST trials used vIGA-AD 0/1 with a ≥2-point improvement as a central endpoint. From a practical standpoint, how well does this endpoint capture meaningful skin clearance for patients with moderate-to-severe disease?
Added By: slingshot_insightsCOAST 1 and COAST 2 support the feasibility of Q12W dosing from initiation. How significant is this for long-term management of atopic dermatitis compared with current biologics that require more frequent administration?
Added By: slingshot_insightsIn COAST 2, amlitelimab did not meet co-primary endpoints under the EU estimand despite meeting US primary endpoints. What factors — statistical, population-based, or regulatory — could explain this divergence?
Added By: slingshot_insightsData from SHORE and the preliminary ATLANTIS analysis suggest progressively increasing efficacy through Week 52 with no clear plateau. How unusual is this pattern in atopic dermatitis biologics, and what might it imply mechanistically?
Added By: slingshot_insightsAmlitelimab selectively blocks OX40-ligand without depleting T cells. How might this upstream immune modulation translate into differences in durability or safety compared with cytokine-targeting agents?
Added By: slingshot_insightsAcross SHORE, COAST, and ATLANTIS, adverse event rates were comparable to placebo and consistent over time. How reassuring is this profile given the inclusion of adolescents and the potential need for long-term treatment?
Added By: slingshot_insightsGiven the totality of Phase 2 and Phase 3 data, what key elements are likely to matter most to regulators when evaluating amlitelimab’s benefit–risk profile for global approval?
Added By: slingshot_insightsAre You Interested In These Questions?
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