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Lebrikizumab

A targeted approach to atopic dermatitis.

Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13 with very high affinity, specifically preventing the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology of atopic dermatitis by promoting type 2 inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening, and infection.

In August 2017, Dermira acquired the exclusive, worldwide rights to develop and commercialize lebrikizumab for atopic dermatitis and other potential indications pursuant to a licensing agreement with Roche. In February 2019, Almirall and Dermira entered into an option and license agreement under which Almirall acquired an option to exclusively license rights to develop and commercialize lebrikizumab for the treatment of atopic dermatitis and other potential indications in Europe, and in June 2019 Almirall exercised its option.

Clinical profile established in multiple Phase 2 studies.

Lebrikizumab has been evaluated in two exploratory Phase 2 clinical studies in adult patients with moderate-to-severe atopic dermatitis. TREBLE, was a double-blind, placebo-controlled study that evaluated the safety and efficacy of lebrikizumab in combination with topical corticosteroids, while ARBAN was an open-label study designed to assess the safety of lebrikizumab as a monotherapy, with an exploratory assessment of efficacy.
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More recently, lebrikizumab was evaluated in a Phase 2b study designed to evaluate the safety and efficacy of lebrikizumab as a monotherapy compared with placebo and to establish the clinical profile for a potential Phase 3 program. Initial positive topline findings from the Phase 2b study were announced in March 2019. In October 2019, detailed primary results were announced, highlighting secondary endpoints that assessed measures spanning the range of signs and symptoms of atopic dermatitis including skin lesions and pruritus.

Based on the Phase 2b study results, Dermira announced the initiation of a Phase 3 clinical development program in October 2019 evaluating the safety and efficacy of lebrikizumab in adult and adolescent patients ages 12 and older with moderate-to-severe atopic dermatitis. The lebrikizumab Phase 3 program includes two identical, randomized, double-blind, placebo-controlled, parallel-group Phase 3 studies designed to confirm the safety and efficacy of lebrikizumab as monotherapy in patients with moderate-to-severe atopic dermatitis. The studies are expected to enroll a total of approximately 800 adult and adolescent patients ages 12 years and older with moderate-to-severe atopic dermatitis at approximately 200 sites in the United States, Europe, and Asia. In addition to the two monotherapy studies, the company plans to include a study in the Phase 3 program that evaluates lebrikizumab when used in combination with topical corticosteroids. The impact of lebrikizumab treatment on quality of life will also be assessed across a number of additional measures. Topline results from the program are expected in the first half of 2021.