Sanofi’s stock dropped in the wake of data from its Phase III trial of atopic dermatitis (AD) candidate amlitelimab, which had been touted as a potential successor to Dupixent.
While the Phase III Coast 1 trial (NCT06130566) met all its primary and secondary endpoints after 24 weeks, it did not exceed the efficacy of Dupixent.
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The trial investigated two dosing regimens: once every four weeks and once every 12 weeks. In the four-weekly dosing cohort, 21.1% achieved clear or almost clear skin, as per the Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD). In the 12-week cohort, this endpoint was achieved in 22.5% of patients. This is compared to 9.2% in the placebo cohort and includes non-responder imputation data.
In addition, 35.9% of patients in the four-weekly dosing and 39.1% in the 12-weekly dosing achieved a 75% or greater improvement in the eczema area and severity index total score (EASI-75).
Sanofi’s stock dropped 8.2% on the news, from a 3 September close of $49.89 to a 4 September open of $45.76 – signalling disappointment from investors.
William Blair analyst Matt Phipps said the magnitude of benefit with amlitelimab came in well below investor expectations based on the Phase II benchmark, with a 20% improvement in the 12-week cohort being well below the 39% improvement over placebo reported in the previous Phase IIb study.
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By GlobalDataThe lower efficacy will also be a hit for Sanofi as amlitelimab, an anti-OX40L monoclonal antibody (mAb), had been touted as Dupixent’s successor, with the blockbuster drug’s patent set to expire in 2030 or 2031.
In 2024, GlobalData reports that Dupixent generated $14.14bn in sales, with a 2031 sales forecast of $25.33bn. GlobalData is the parent company of Clinical Trials Arena.
Phipps said: “Overall, the results add to the evidence suggesting OX40 or OX40L targeting therapies do not drive deep responses as fast as the IL-13/4 class, and therefore may relegate the class to second-line biologic for patients not responding to IL-13/4 therapies.”
Another OX40 therapy that disappointed at Phase III was Amgen and Kyowa Kirin’s rocatinlimab, with data being on par with amlitelimab. Phipps added, however, that the drugs do provide a favourable, less frequent dosing schedule compared to Dupixent, with the potential for monthly or quarterly dosing, respectively.
GlobalData predicts sales of amlitelimab to reach $644m in 2031. Sanofi gained rights to amlitelimab through a $1.1bn acquisition of Kymab in 2021.
The AD announcement comes five months after mixed Phase II data of amlitelimab in asthma, but Sanofi said it will advance the drug to Phase III trials.
GlobalData predicts the AD market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) to reach $22.4bn by 2033.
