LEO Pharma said Wednesday that the experimental drug tralokinumab met all primary and secondary endpoints in three pivotal Phase III studies for the treatment of moderate-to-severe atopic dermatitis in adults. The company indicated that it plans to submit marketing applications for the agent in 2020.
According to LEO Pharma, the ECZTRA 1 and ECZTRA 2 trials included 802 and 794 adults, respectively, with moderate-to-severe AD who are candidates for systemic therapy and were designed to evaluate tralokinumab monotherapy. Meanwhile, the ECZTRA 3 study included 380 adults with moderate-to-severe AD who are candidates for systemic therapy and was designed to investigate tralokinumab in combination with topical corticosteroids.
The main goals of the trials were an Investigator Global Assessment (IGA) score of clear or almost clear skin at week 16 and at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score at week 16. Meanwhile, secondary endpoints were change from baseline to week 16 in SCORing of Atopic Dermatitis (SCORAD), Pruritus Numeric Rating Scale (NRS) of at least 4, and Dermatology Life Quality Index (DLQI). LEO Pharma noted that in the studies, the overall adverse event rate was comparable between tralokinumab and placebo.
Tralokinumab is a fully human, immunoglobulin G4 monoclonal antibody that works by neutralising the interleukin (IL)-13 cytokine. LEO Pharma gained rights to the therapy in dermatology indications from AstraZeneca in 2016 as part of a deal potentially worth more than $1 billion.
Sanofi and Regeneron Pharmaceuticals' Dupixent, which inhibits IL-4 and IL-13, gained US and European approval in 2017 adults with moderate-to-severe atopic dermatitis. Meanwhile, Dermira recently received FDA fast-track designation for its experimental drug lebrikizumab for the treatment of patients with moderate-to-severe atopic dermatitis. The agent, which targets IL-13, is currently being investigated in the late-stage ADvocate 1 and ADvocate 2 trials in patients ages 12 years and older with moderate-to-severe atopic dermatitis.
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