By VETTAPHARMA reporter: French biopharmaceutical company Sanofi reported encouraging clinical data supporting the potential of its investigational therapy amlitelimab for the treatment of atopic dermatitis (AD), paving the way for global regulatory submissions.
In the SHORE phase 3 trial, amlitelimab used in combination with topical therapies met all primary and key secondary endpoints at Week 24. The study demonstrated steadily increasing efficacy throughout the treatment period, with some patients showing improvement as early as Week 2.
The COAST 2 phase 3 trial showed that amlitelimab achieved statistically significant efficacy on vIGA-AD 0/1, the primary endpoint, in patients from the United States and U.S. reference countries, and supported the potential for every-12-week (Q12W) dosing from treatment initiation, consistent with findings from COAST 1. However, the therapy did not meet statistical significance for the co-primary endpoints in patients from the European Union and EU reference countries.
Additionally, a preliminary analysis from the ATLANTIS phase 2 study indicated continued and progressive clinical improvement through Week 52, with no evidence of a plateau in response. The results underscore the potential of OX40-ligand inhibition as a novel mechanism for the treatment of atopic dermatitis.
How the 2 Phase 3 studies differed (SHORE and COAST 2)?
The SHORE and COAST 2 studies differed primarily in treatment approach, patient management, and geographic scope, despite sharing similar phase 3 designs and dosing regimens. SHORE evaluated amlitelimab in combination with topical standard-of-care therapies, allowing participants to use topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI) alongside the investigational drug, reflecting a real-world adjunctive treatment setting. In contrast, COAST 2 assessed amlitelimab as a monotherapy, with no background topical treatments permitted, to isolate the drug’s standalone efficacy. SHORE enrolled 596 participants and included broader regional representation across North America, the EU, and select countries in Latin America and Asia, while COAST 2 enrolled 547 patients and was conducted across a slightly different global footprint, including the US, UK, EU, Africa, and Asia.
Primary endpoints:
SHORE (Phase 3)
Primary Endpoints (measured at Week 24)
- Accessed for US and EU estimands: “vIGA-AD 0/1: Proportion of patients achieving a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline.”
COAST 2 (Phase 3)
Primary Endpoint (US and US reference countries, Week 24):
- Accessed for US and US reference countries: proportion of patients achieving vIGA-AD 0/1 and a reduction from baseline score of ≥2 points compared to placebo at Week 24, as assessed for the US and US reference countries
- EASI-75: Proportion of patients achieving ≥75% improvement in EASI score.
Sanofi plans to present the aggregated results from COAST 1, COAST 2, SHORE, and ATLANTIS at upcoming medical congresses, with global regulatory submissions anticipated in the second half of 2026.
Source credit:
- Sanofi. (2026, January 23). Sanofi’s amlitelimab confirms its potential in atopic dermatitis [Press release]. Click here
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