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Lebrikizumab maintains skin clearance over one year in atopic dermatitis monotherapy trials

Almirall recently announced topline results from one-year analyses of the efficacy and safety of lebrikizumab, an investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe atopic dermatitis (AD)

almirall
Healthcare

Almirall recently announced topline results from one-year analyses of the efficacy and safety of lebrikizumab, an investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Additionally, patients treated with lebrikizumab maintained itch relief across the two trials over the one-year period. These results build upon positive data from the 16-week, double-blind, placebo-controlled part of the ADvocate program. 

“We are pleased to witness how lebrikizumab has proven over a year its potential to be a leading option for the treatment of atopic dermatitis. ADvocate 1 and 2 results add to the exciting, growing body of evidence from our Phase 3 clinical trial program and demonstrate that this medicine may provide much-needed relief for those seeking new treatment options. We look forward to continuing our collaboration with Lilly and advancing in our clinical program, aiming to obtain approval in the European Union,” stated Karl Ziegelbauer, Ph.D., Almirall’s Chief Scientific Officer.  

AD, or atopic eczema, is a chronic, relapsing, heterogenous skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body. Lebrikizumab is a novel, monoclonal antibody (mAb) that binds to the interleukin-13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13Rα1/IL-4Rα (Type 2 receptor) which blocks downstream signaling through the IL-13 pathway. IL-13 plays the central role in AD, promoting Type 2 inflammation that drives skin barrier dysfunction, itch, skin thickening and infection.

With the complete data for week 52, Almirall plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for lebrikizumab in AD in the second half of 2022. Lilly also plans to submit an application to the U.S. Food and Drug Administration (FDA) this year, followed by submissions to other regulatory agencies around the world.