Almirall S.A. (BME:ALM), a biopharmaceutical company focused on medical dermatology, on Friday released the initial two-year findings from the ADjoin long-term extension study.
These results reveal that patients with moderate-to-severe atopic dermatitis who maintained treatment with investigational lebrikizumab for up to two years enjoyed sustained skin clearance, itch relief and reduced disease severity with monthly maintenance dosing. The data was unveiled at the 43rd Annual Fall Clinical Dermatology Conference in Las Vegas, Nevada.
Lebrikizumab is an interleukin-13 (IL-13) inhibitor targeting the critical cytokine IL-13 in atopic dermatitis.
According to Prof. Dr. med. Diamant Thaçi, director at the Institute and Comprehensive Centre for Inflammation Medicine in Lübeck, Germany, the monthly maintenance dose of lebrikizumab offers new hope to nearly 80% of patients, enabling them to maintain clear or almost clear skin for an extended period.
The ADjoin study represents a two-year extension of the lebrikizumab monotherapy trials ADvocate 1 and ADvocate 2 and ADhere, the combination trial with topical corticosteroids. Patients who had achieved IGA 0,1 or EASI-75 at 16 weeks in ADvocate 1 and 2 and ADhere were enrolled in ADjoin, receiving lebrikizumab 250 mg every two weeks or monthly.
In ADjoin, lebrikizumab demonstrated enduring efficacy in skin and itch outcomes over the two-year treatment period, and the safety profile remained consistent with prior lebrikizumab studies for moderate-to-severe atopic dermatitis patients. No new safety concerns were identified throughout the two-year duration.
These findings build upon the positive one-year results published in the British Journal of Dermatology and the 16-week monotherapy data published in The New England Journal of Medicine. Almirall holds licensing rights for lebrikizumab development and commercialisation in Europe, while pharmaceutical company Eli Lilly and Company (NYSE:LLY) has exclusive rights for development and commercialisation in the United States and the rest of the world outside Europe.
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