Almirall S.A., a global biopharmaceutical company focused on medical dermatology, today announced the presentation of new data on lebrikizumab through 18 abstracts, including two oral presentations at the European Academy of Dermatology and Venereology (EADV) Congress held in Berlin from October 11th to 14th. 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 3 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 3 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 ≤7 (mild) and EASI ≤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.
“Atopic dermatitis (AD) is a debilitating chronic skin condition that can be challenging to manage. Cyclosporine A is the only classical systemic treatment approved in Europe for AD, but its safety may limit long-term use, or it may be contraindicated for some patients”, said Prof. Dr. Ricard B. Warren, Professor of Dermatology and Honorary Consultant Dermatologist at the University of Manchester and Northern Care Aliance NHS Foundation Trust; principal investigator of the ADvantage trial. “Although there are an increasing number of treatment options available to ease symptoms and improve outcomes of AD, unfortunately there are few that offer long-term disease control with a favorable safety profile. The results of this trial reinforce our confidence that lebrikizumab is a promising potential new treatment for patients with moderate-to-severe AD, including those not adequately controlled or ineligible for treatment with cyclosporine A.”
“The new lebrikizumab data set presented at the EADV congress provides further evidence of its efficacy and safety profile. Its anticipated addition to the moderate-to-severe AD treatment arsenal is promising news for both healthcare professionals and patients, including those who do not respond adequately to cyclosporine. Our teams are diligently working to increase our level of knowledge and expand the body of evidence, thereby reinforcing the profile of this potential first-line treatment”, stated Karl Ziegelbauer, Ph.D., Chief Scientific Officer at Almirall.
Almirall received a positive CHMP opinion in September, recommending marketing authorization for lebrikizumab for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe AD who are candidates for systemic therapy. The CHMP opinion is based on three pivotal Phase 3 studies including ADvocate 1 and ADvocate 2, evaluating lebrikizumab as monotherapy, and ADhere, assessing lebrikizumab in combination with TCS, in adult and adolescent patients with moderate-to-severe AD.
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.