Leo Pharma has announced long term safety and efficacy data for its atopic dermatitis treatment, Adbry (tralokinumab-ldrm), demonstrating the drug’s ability to drive clear or almost clear skin for up to six years.
Among patients enrolled in the Phase III ECZTEND study (NCT03587805) who have were on long-term (maintenance) treatment with Adbry, 92.9% of patients observed a reduction of at least 75% on the Eczema Area and Severity Index (EASI-75) at week 248. Additionally, 66.7% of patients achieved clear or almost clear skin, as assessed by the Investigator’s Global Assessment (IGA) scale. No new safety signals were identified.
The results were presented in a poster at the Fall Clinical Dermatology Conference, which was held in Las Vegas, Nevada from 24-27 October.
Adbry was approved by the US Food and Drug Administration (FDA) in 2021 for the treatment of adults with moderate-to-severe atopic dermatitis. The label was expanded in 2023 when Adbry gained an FDA approval for use in adolescents aged 12 and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
An alternative mode of administration after the approved by the FDA its single dose autoinjector in June 2024. In 2023, LEO generated net sales of DKK 11.4bn ($1.7bn), growth which was driven by growth of Adbry, as per the company’s 2023 annual results. GlobalData’s consensus forecasts project that Adbry will generate global sales of $1.3bn in 2030.
Participants enrolled in the open label ECZTEND were previously assessed in multiple monotherapy and combination therapy studies of Adbry. Among these studies are the Phase III ECZTRA 1 (NCT03131648) and ECZTRA 2 (NCT03160885) studies of monotherapy Adbry and the Phase III ECZTRA 3 study (NCT03363854) of a Adbry/topical corticosteroid combination therapy. Patients were eligible to enroll in ECZTEND after completion of their respective parent trials regardless of their treatment response or whether they received Adbry or placebo treatment.
Adbry targets interleukin-13 (IL-13), a cytokine that drives inflammatory processes that drive symptoms of atopic dermatitis.
Source: pharmaceutical-technology.com
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