Clinical Trials

The trial showed sustained improvement of signs and symptoms of AD for 28 weeks, as well as high responder rates also being observed in participants who were taken off the drug.

The safety profile of amlitelimab remained consistent with what was reported in part 1 of the study, with the drug being well tolerated and no new safety concerns being identified.

These results were presented at the American Academy of Dermatology (AAD) 2024 Conference, which took place in San Diego, US, and support the quarterly dosing of the drug at 250mg and 500mg, which is now being investigated in a larger phase 3 trial.

Naimish Patel MD, head of global development, immunology and inflammation at Sanofi, commented: “It’s unprecedented to see this type of durability of clinical response, which we believe could be very meaningful to patients and is the reason why we selected an every 12-week dosing regimen in the AD pivotal programme. AD is a chronic, lifelong disease, which means we must strive to provide a portfolio of solutions to patients that matches their individual needs and puts as little burden on them as possible. We are also moving with speed in our exploration of amlitelimab's potential in five other chronic inflammatory diseases, including asthma, hidradenitis suppurativa, scleroderma, coeliac disease and alopecia. In addition, we are exploring six other innovative mechanisms of action (MOAs) in eight dermatologic indications underscoring our commitment to patients with high unmet medical needs.”

Professor Stephan Weidinger MD PhD, director, professor and chair of the Department ofDermatologyandAllergy,UniversityHospital Schleswig-Holstein, Germany, added: “Despite available treatment options, not all patients with moderate-to-severe atopic dermatitis 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. 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.”