Sanofi announced positive results from three phase 3 studies of amlitelimab, a fully human non-T cell depleting monoclonal antibody that selectively targets OX40-ligand (OX40L), in moderate-to-severe atopic dermatitis (AD) as a monotherapy and in combination with topical therapies, showed improvements in skin clearance and disease severity with amlitelimab treatment compared to placebo in patients aged 12 years and older. The studies, COAST 1 (clinical study identifier: NCT06130566), COAST 2 (clinical study identifier: NCT06181435) and SHORE (clinical study identifier: NCT06224348) were presented during the late-breaking research session at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, US. In these studies, amlitelimab was generally well-tolerated.

Primary and key secondary endpoints in COAST 1, COAST 2, and SHORE were assessed at Week 24 in patients who received amlitelimab either every four weeks (Fourth Quarter) or every 12 weeks (Twelfth Quarter) with or without topical medications. For US and US reference countries, the primary endpoint for all studies was the proportion of patients with a validated investigator global assessment scale for AD (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline score of =2 points. In the COAST 1 and COAST 2 studies, amlitelimab met the primary endpoint.

In COAST 1, key secondary endpoints, including vIGA-AD 0/1 with barely perceptible erythema (BPE), the proportion of patients reaching a 75% or greater improvement in the eczema area, severity index total score (EASI-75), and a =4-point reduction in peak pruritus-numerical rating scale (PP-NRS) were statistically significant. In COAST 2, EASI-75 and PP-NRS=4 reached nominal significance; vIGA-AD 0/1 with BPE did not reach statistical significance. In the SHORE study, amlitelimab in combination with topical corticosteroids (TCS) with or without topical calcineurin inhibitors (TCI), dosed at both Q4W and Q12W, demonstrated significant improvements in AD clinical signs and symptoms versus placebo as measured across primary and key secondary endpoints at Week 24.

In the COAST 1, COAST 2, and SHORE studies, the safety profile of amlitelimab was consistent with previously reported data. In COAST 1, the most common treatment-emergent adverse events (TEAEs, =5% in any dose arm; pooled amlitelimab vs placebo) were nasopharyngitis (7.3% vs 10.5%), dermatitis atopic (7.3% vs 22.4%), and upper respiratory tract infection (5.3% vs 8.6%). In COAST 2, the most common TEAEs were nasopharyngitis (5.9% vs 7.4%), dermatitis atopic (5.3% vs 2.7%), and upper respiratory tract infection (4.8% vs 4.0%).

The most common TEAEs in the SHORE study included nasopharyngitis (9.5% vs 12.5%), upper respiratory tract infection (7.9% vs 4.4%) and dermatitis atopic (2.7% vs 5.6%). In addition, across the three studies, the incidence of pyrexia, chills and headaches were low, with the majority not injection-related. Malignancy rates were low (<1%) and generally similar between amlitelimab and placebo groups.

There were no events of severe injection site reactions, serious gastrointestinal ulceration, or Kaposi?s sarcoma (KS). Cumulatively, a total of two KS cases, both in patients with known risk factors, were reported out of 3,778 patients confirmed to have been exposed to amlitelimab across all indications. One was previously presented at the Winter Clinical Miami conference from the open-label ATLANTIS phase 2 study (clinical study identifier: NCT05769777).

At the AAD meeting, Sanofi presented the second case, identified in the still-blinded ESTUARY phase 3 study (clinical study identifier: NCT06407934). In each case, the patient stopped treatment with amlitelimab and is in the recovery phase. Sanofi has not identified any further cases of KS across an estimated 4,630 patients in the full amlitelimab development program, including still-blinded studies.

Sanofi believes that amlitelimab continues to have the potential to be a meaningful and convenient option for patients with AD. Results from ESTUARY, a phase 3 extension study evaluating Q12W maintenance dosing and longer-term safety, are anticipated in H2 2026.

https://www.marketscreener.com/news/sanofi-presents-new-results-from-amlitelimab-phase-3-studies-in-atopic-dermatitis-ce7e51d8dc8ef626