Sanofi has announced positive results from a phase 2b study of its investigational amlitelimab, which the company says “support the potential for best-in-class maintenance of response” in moderate-to-severe atopic dermatitis (AD).

Results from the STREAM-AD study were recently presented as part of a late-breaking session at the American Academy of Dermatology 2024 Conference in San Diego, US.

Otherwise known as eczema, AD is a chronic, inflammatory skin disease characterised by recurrent dry, itchy and inflamed skin.

The randomised, double-blind placebo-controlled study evaluated amlitelimab in adults patients from several countries, including Australia, the US and the UK, with moderate-to-severe AD whose disease was inadequately controlled with topical therapies or where these were not advisable.

Amlitelimab is a fully human non-T cell-depleting monoclonal antibody that blocks a key immune regulator known as OX40-Ligand to restore balance between pro-inflammatory and regulatory T cells.

The study showed sustained improvements in signs and symptoms for 28 weeks in patients who previously responded to amlitelimab and continued treatment.

In the second phase of the trial, patients who previously achieved a 75% improvement in eczema area and severity index score (EASI) and/or investigator global assessment (IGA) score of zero or one during the 24-week period were randomised to continued amlitelimab treatment or withdrawal for 28 weeks.

In approximately 69.2% of patients who continued treatment with amlitelimab 250mg with 500mg loading doses versus 58.8% of patients withdrawn from treatment, IGA zero to one and/or EASI-75 response were maintained.

Quarterly dosing of amlitelimab 250mg with 500mg loading doses is now being investigated as part of a larger phase 3 clinical programme, OCEANA.

Naimish Patel, head of global development, immunology and inflammation, Sanofi, said: “It’s unprecedented to see this type of durability of clinical response, which we believe could be very meaningful to patients.”