Sanofi is excited for 2026. At the JP Morgan Healthcare conference, several upcoming catalyst events were highlighted, including high-profile read-outs, regulatory submissions, and regulatory decisions.
Among these, one that will be keenly watched is Phase III COAST-2 (NCT06181435) data readout for amlitelimab for atopic dermatitis (AD), which, if positive, will pave the way for amlitelimab’s regulatory submission as first-in-class OX40-ligand inhibitor and could potentially reinvigorate Sanofi’s AD portfolio beyond Dupixent.
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The purpose of the COAST 1 study (NCT06130566) was to measure the efficacy and safety of treatment with amlitelimab in individuals with moderate-to-severe AD. The primary endpoint was to assess the proportion of participants with Validated Investigator Global Assessment scale for AD (vIGA-AD) of 0 (clear) or 1 (almost clear) after 24 weeks in comparison to individuals administered a placebo. Additionally, secondary outcome measures included the proportion of participants reaching a 75% reduction from baseline in Eczema Area and Severity Index (EASI-75) after 24 weeks in comparison to placebo.
In September 2025, Sanofi announced that amlitelimab met all primary and secondary endpoints in the COAST 1 Phase III clinical trial, demonstrating its clinical significance and meaningful efficacy in skin clearance and disease severity. It was also reported that efficacy progressively increased throughout the treatment period. Furthermore, the drug was well-tolerated with no new safety concerns identified within the study.
The currently ongoing COAST 2 Phase III clinical trial aims to further test the efficacy and safety of amlitelimab in individuals with moderate-to-severe AD with primary and secondary endpoints similar to the COAST 1 clinical trial. There were no major population recruitment strategies in COAST 2 compared to COAST 1. Researchers at Sanofi are hopeful that the COAST 2 clinical trial reaches its indicated primary and secondary endpoints, which would allow the company to begin entry into filing and submission, with aims to reach approval.
The prospect of amlitelimab’s four-time-per-year dosing is a key differentiator compared to current therapy option such as Dupixent, which is administered biweekly or monthly and represents a significant quality-of-life advantage. Sanofi’s leadership team shared the sentiment that they would like to see similar results for the Phase III COAST 2 trial, data read-out of which is anticipated in the first half of 2026. Additionally, the CEO acknowledged that it will be “one of the most important moments in AD” if amlitelimab is able to deliver treatment outcomes with an increasing efficacy profile beyond 24 weeks.
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By GlobalDataWhile amlitelimab’s efficacy profile does not appear to surpass that of Dupixent, it offers meaningful differentiation through its dosing frequency and novel OX40L mechanism of action. This differentiation may support its wider adoption across specific patient populations, positioning itself within an increasingly competitive AD market. Furthermore, amlitelimab represents a key pipeline asset for Sanofi as the company prepares for Dupixent’s loss of exclusivity, providing a potential revenue bridge within its immunology pipeline. The drug is anticipated to launch in 2027 and is forecast to generate over $1bn in revenue by 2031, highlighting its role in offsetting revenue losses within Sanofi’s AD portfolio.
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