Sanofi says that its experimental drug amlitelimab has the potential to become a ‘best-in-class’ maintenance therapy for atopic dermatitis (AD) after reporting new phase 2b data.
The latest results from the STREAM-AD trial suggest that the anti-OX40L antibody – acquired as part of Sanofi’s $1.45 billion takeover of Kymab in 2021 – could be used to control AD symptoms with an injection given just once every three months.
Sanofi is already a major player in the ASD market with its big-selling IL-4 and IL-13 inhibitor Dupixent (dupilumab), and the company has previously highlighted amlitelimab as one of a dozen pipeline projects that could become future blockbuster products.
Naimish Patel, head of global development, immunology and inflammation, at the pharma group, said the durability seen with amlitelimab is “unprecedented,” adding that three-monthly dosing of the antibody is now being tested in phase 3 studies. Dupixent is generally dosed every two or four weeks for AD.
At the American Academy of Dermatology (AAD) congress in San Diego, data from STEAM-AD showed that amlitelimab achieved sustained improvement of signs and symptoms over 28 weeks in adults with moderate to severe AD who previously responded to amlitelimab and continued treatment with the drug.
Safety data is also available out to 52 weeks and was consistent with the results seen at the study’s main endpoint of 24 weeks, showing the drug was well tolerated, according to Prof Stephan Weidinger of University Hospital Schleswig-Holstein in Germany, who presented the results at the meeting.
“Despite available treatment options, not all patients with moderate-to-severe AD respond sufficiently to these treatments, and many continue to suffer from skin lesions and symptoms such as persistent itch, which can have a high impact on their day-to-day lives,” he said.
“Results from this part of the study indicate amlitelimab’s potential for durable off-drug efficacy which supports the evaluation of a less frequent every 12-week dosing. This could offer an important benefit in the treatment of AD patients.”
Sanofi is running four phase 3 trials of amlitelimab, including two placebo-controlled studies of the drug as a monotherapy in adults with moderate-to-severe AD (COAST 1 and 2), a study looking at the drug in combination with background topical corticosteroids (SHORE), and another steroid combination trial focusing on patients who have had an inadequate response to other biologic AD therapies (AQUA). It hopes to file for approval of the drug in 2026.
Like Dupixent, which has multiple indications across five inflammatory diseases, Sanofi views amlitelimab as a “pipeline-in-a-product” with the potential to reap sales of €5 billion ($5.4 billion) or more at its peak.
The company has also started testing the drug in severe asthma and hidradenitis suppurativa (HS) and is planning studies in scleroderma, coeliac disease, and alopecia.
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