Lebrikizumab improves signs and symptoms of moderate-to-severe atopic dermatitis in patients inadequately controlled with or ineligible for cyclosporine.- Almirall S.A.

Among the new data presented, lebrikizumab showed clinical improvements in combination with topical corticosteroids (TCS) in adult and adolescent patients with moderate-to-severe AD not adequately controlled with cyclosporine or for whom cyclosporine was not medically advisable, who were assessed over 16 weeks in the Phase III ADvantage study (NCT05149313). The safety was consistent with the known safety profile of lebrikizumab.

Further data presented at the congress showed sustained depth of response in patients that participated in the Phase III monotherapy Advocate 1 and 2 studies treated with lebrikizumab over 52 weeks. Deep responses, defined as total skin clearance (Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI)100) and itch relief (NRS 0,1), were achieved in 20 and 31 percent of patients by Week 16 respectively and were maintained or increased through Week 52.

Lebrikizumab also provided long-term clinically meaningful responses in patients, offering a multi-dimensional benefit that help achieve disease control.

In a post-hoc analysis of the ADvocate 1 and 2 studies, 84 percent of patients who had responded to lebrikizumab at Week 16 achieved a clinically meaningful response in at least one domain of the disease (mild signs, symptoms or quality of life impact) after 52 weeks, and more than 57 percent achieved response across the three domains. This represents a status of minimal residual disease.

Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared. A post-hoc analysis of the ADvocate1 and ADvocate2 trials showed that, overall, a significantly higher proportion of patients treated with lebrikizumab achieved EASI less than 7 (mild) and EASI less than 1 (clear/almost clear) at Week 16 compared to placebo. This analysis also demonstrated that, regardless of baseline severity, over 50 percent of patients treated with lebrikizumab 250 mg every other week on monotherapy for 16 weeks achieved an EASI score indicating mild AD and approximately 20 percent achieved an EASI score indicating clear or almost clear skin.

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of the product in the United States and the rest of the world, not including Europe. Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe AD in additional European markets, including the United Kingdom and Switzerland in 2024.