Eight out of ten patients maintained skin clearance at one year in lebrikizumab atopic dermatitis monotherapy trials.

Eli Lilly and Company announced topline results from one-year analyses of the efficacy and safety of lebrikizumab, the company's investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe atopic dermatitis (AD).

The new findings from the Phase III 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.

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-13R alpha1/IL-4R alpha (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.

In ADvocate 1, 79% of patients who received lebrikizumab every four weeks and 79% of patients who received lebrikizumab every two weeks maintained 75% or greater skin improvement (EASI-75) at one year of treatment. Additionally, 85% of patients who received lebrikizumab every four weeks and 77% of patients who received lebrikizumab every two weeks maintained EASI-75 response in ADvocate 2 at one year of treatment. The frequency of adverse events and the overall safety profile among these patients treated with lebrikizumab were consistent with the induction phase of the trials as well as previous lebrikizumab studies in AD. No new safety signals were observed in this patient population.

With these data, Lilly plans to submit a Biologics License Application (BLA) to the FDA for lebrikizumab in AD in the second half of 2022, followed by submissions to other regulatory agencies around the world. Almirall also plans to submit these results this year to the European Medicines Agency (EMA) for authorization.