Sanofi has debuted the long-awaited results from two Phase III studies of its potential Dupixent (dupilumab) successor, amlitelimab, in atopic dermatitis (AD) – with the data having garnered a generally positive analyst reaction.
During the COAST 2 study (NCT06181435), amlitelimab met one of the trial’s co-primary endpoints of the proportion of US and US reference country patients achieving validated investigator global assessment for atopic dermatitis scores of 0 or 1 (vIGA-AD 0/1), and a ≥2-point reduction in vIGA-AD after 24 weeks.
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In the study, 25.3% of patients who received monthly amlitelimab and 25.7% who received quarterly doses of the drug achieved this endpoint in the US and US reference countries. This is compared to 14.8% of patients in the placebo cohort achieving the endpoint.
However, the drug narrowly missed its EU and EU reference country co-primary endpoint, which required a significant proportion of patients to reach vIGA-AD 0/1, as well as a 75% reduction in eczema severity (EASI-75).
Amlitelimab also had no significant impact on the proportion of US and US reference country patients achieving vIGA-AD 0/1 with barely perceptible erythema (BPE), missing out on the trial’s secondary endpoint.
SHORE study secures win
Though amlitelimab’s demonstrated mixed results in the COAST 2 trial, the Phase III SHORE study (NCT06181435) demonstrated the drug’s potential alongside topical corticosteroids.
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By GlobalDataIn EU patients, when given once-quarterly, 32.9% of patients dosed with amlitelimab achieved vIGA-AD 0/1 – significantly higher than the 16.8% rate seen in the placebo group by week 24. When given once monthly, 29.9% of patients achieved this endpoint.
In the same patient population, the EASI-75 endpoint was achieved in 48.1% of patients treated with once-quarterly amlitelimab and 50.9% in the monthly dosing group after 24 weeks, while 34.2% of those in the placebo group experienced the same outcome.
In US patients, 28.7% who were dosed monthly and 32.3% who were dosed quarterly, both alongside topical corticosteroids, achieved vIGA-AD 0/1, while 16.8% of patients who received placebo achieved this endpoint. EASI-75 was achieved in 48.1% of patients given amlitelimab monthly and 46.8% given amlitelimab quarterly compared to 32.3% of placebo patients.
These data include all patients regardless of rescue medication use prior to week 24.
In both the COAST 2 and SHORE studies, amlitelimab was proven safe and tolerable, with the most common treatment-related adverse events (AEs) being nasopharyngitis and upper respiratory tract infections.
Results of the SHORE and COAST 2 studies follow the positive outcome of the Phase III COAST 1 trial (NCT06130566) back in September 2025, which saw the trial meet all its primary and secondary endpoints. Though amlitelimab demonstrated efficacy in this AD trial, the drug failed to best the clinical profile of the company’s blockbuster medication, Dupixent (dupilumab), sending Sanofi’s stock sliding.
Sanofi’s executive VP and R&D head, Houman Ashrafian, noted that data collected from these late-stage trials in AD reinforce the French pharma’s confidence in amlitelimab as a once-quarterly therapy.
According to Ashrafian, Sanofi will now vie for amlitelimab’s global approval in AD – though no extra details on this process were shared.
Finding an heir to Dupixent’s throne
The market success of amlitelimab in AD, more commonly known as eczema, could be particularly important for Sanofi, as one of the company’s best-selling assets, Dupixent, will soon be exposed to biosimilar competition upon its patent expiry in 2031.
According to Tanuj Sircar, associate director of Competitive Intelligence at GlobalData, the results of the COAST 1, 2 and SHORE studies “pave the way for regulatory submissions given the totality of evidence”.
“Amlitelimab has demonstrated good efficacy as a monotherapy as well as in combination with topical corticosteroids and calcineurin inhibitors. It has also been proven effective as a long-term treatment, further cementing the viability of OX40 ligand inhibition in AD,” Sircar commented.
Sircar also touted the drug safety profile, which differs to Amgen & Kyowa Kirin’s investigative competitor anti-OX40 biologic, rocatinlimab, by avoiding safety issues such as pyrexia, chills and aphthous ulcers – likely due to its differentiated mechanism of action.
Though amlitelimab did not manage to best Dupixent in terms of efficacy, Sircar noted that the data suggest amlitelimab may be “slower-acting and potentially driven by deep immune rebalancing long-term,” while offering a differentiated dosing profile.
However, he did add that partial shortcomings in endpoints may “open a weak point for competitors to exploit”.
Overall, Sircar forecasts that amlitelimab will find its best use case as a second- or third-line systemic therapy that can avoid class-specific events like conjunctivitis, which are commonly seen with Dupixent, Adtralza/Adbry (tralokinumab-ldrm) and Ebglyss (lebrikizumab), or major adverse events associated with JAK inhibitors such as Rinvoq (upadacitinib) and Cibinqo (abrocitinib).
