Eli Lilly has released results from the Phase III Admirable trial of its monoclonal antibody, lebrikizumab, in patients with darker skin tones with moderate to severe atopic dermatitis, also known as eczema.
The data from the Phase III trial (NCT05372419) was presented at the American Academy of Dermatology (AAD) Annual Meeting taking place in San Diego from 8-12 March. The study evaluated lebrikizumab in 50 patients over 16 weeks, including people who self-identify as Black or African American (80%), Hispanic/Latinx (22%), Asian (14%), American Indian or Alaska Native (6%).
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At least 68% of the patients receiving lebrikizumab experienced an improvement of 75% in their disease extent and severity measured using the Eczema Area and Severity Index (EASI). Approximately 46% of the participants showed an improvement of at least 90% in disease extent and severity.
Approximately 39% of the trial participants achieved clear or almost clear skin measures using the Investigator’s Global Assessment Scale (IGA), reducing at least two points from baseline. IGA is a five-point scale with ‘0’ signifying clear skin and ‘5’ signifying very severe atopic dermatitis. About 56% of the study participants also experienced clinically meaningful itch relief measured using a ten-point Pruritus Numeric Rating Scale (PNRS) in participants with a baseline PNRS of ≥4.
Lebrikizumab is an interleukin 13 (IL-13) targeting humanised monoclonal antibody, which acts by driving the type-2 inflammatory loop in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection. The therapy is expected to generate more than $3bn in global sales by 2029, as per GlobalData analysis.
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By GlobalDataLilly has also reported data from other Phase III trials, namely ADvocate 1 (NCT04146363) and ADvocate 2 (NCT04178967), evaluating lebrikizumab in patients with moderate to severe atopic dermatitis. The company has also filed for regulatory approval for the drug to the US Food and Drug Administration (FDA). However, the US agency declined to approve the monoclonal antibody citing manufacturing issues.
Lebrikizumab was approved to treat adult and adolescent patients with moderate-to-severe atopic dermatitis by the European Commission in November 2023. The therapy is marketed under the brand name Ebglyss by Lilly’s partner Almirall in Europe. Lilly holds the worldwide development and commercialisation rights, except in Europe, to lebrikizumab.
