On Friday, March 28 2026, Sanofi presented positive Phase 3 results for amlitelimab in moderate‑to‑severe atopic dermatitis at the American Academy of Dermatology meeting in Denver. The three studies—COAST 1, COAST 2, and SHORE—met or exceeded the primary endpoint of achieving a clear or almost clear skin assessment (vIGA‑AD 0/1) at week 24.
In COAST 1, vIGA‑AD 0/1 response rates were 21‑23% versus 9% for placebo, and EASI‑75 rates were 36‑39% versus 19%. COAST 2 showed 25.3‑25.7% versus 14.8%, while SHORE reported 28.7‑32.3% versus 16.8%. These results confirm a consistent benefit across all three trials and support the drug’s potential as a once‑every‑12‑weeks therapy.
The safety profile remained favorable, with no new signals. Two cases of Kaposi’s sarcoma were reported in patients with known risk factors; both patients discontinued treatment and recovered. The overall incidence of serious adverse events was low, reinforcing the tolerability of the antibody.
Sanofi plans global regulatory submissions for amlitelimab in the second half of 2026, positioning the drug as a potential successor to Dupixent as its patent life approaches. The company highlighted that the data strengthen the case for a Q12W dosing schedule, which could differentiate the product in a crowded biologic market.
While the results are positive, investors have previously reacted to earlier topline announcements in September 2025 and January 2026, noting that amlitelimab’s efficacy, though statistically significant, is lower than Dupixent’s pivotal outcomes. The lower efficacy has been a recurring theme in market discussions, though the convenience of less frequent dosing remains a potential advantage.
Executive Vice President Houman Ashrafian said, “The totality of data shared at AAD reinforce the progressive improvement in efficacy seen with amlitelimab over the course of treatment and the potential for Q12W dosing from the start.” He added that the data support amlitelimab as a meaningful option for patients with atopic dermatitis.
Dermatology professor Eric Simpson noted, “Despite current medicines, a critical medical gap remains for moderate‑to‑severe atopic dermatitis patients and additional treatment options are needed. These data, which show that amlitelimab delivers potentially progressive efficacy over time, further illustrate the potential of non‑T cell depleting OX40L inhibition to help reduce disease severity and burdensome symptoms with less frequent dosing.”
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