Lebrikizumab Achieved Skin Clearance in Lilly's Pivotal Phase 3 Atopic Dermatitis Studies

 More than 50% of patients with moderate-to-severe atopic dermatitis (AD) experienced at least 75 % reduction in disease severity (EASI-75) at 16 weeks when receiving lebrikizumab monotherapy in the ADvocate program, Eli Lilly and Company announced at the American Academy of Dermatology (AAD) Annual Meeting. Lebrikizumab, an investigational IL-13 inhibitor, also led to clinically meaningful improvements in itch and other important patient-reported outcomes compared to placebo. Lebrikizumab is a monoclonal antibody (mAb) that binds to the interleukin 13 (IL-13) protein with high affinity to specifically prevent the formation of IL-13Ra1/IL-4Ra (Type 2 receptor) which blocks downstream signaling through the IL-13 pathway. 1-5 IL-13 plays the central role in Type 2 inflammation.6 In AD, IL-13 underlies the signs and symptoms including skin barrier dysfunction, itch, infection and hard, thickened areas of skin. In ADvocate 1, 43 % of patients receiving lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks compared to 13 % of patients taking placebo. Among those receiving lebrikizumab, 59 % achieved an EASI-75 response, compared to 16 % with placebo. In ADvocate 2, 33 % of patients taking lebrikizumab achieved clear or almost clear skin (IGA) at 16 weeks, compared to 11 % of patients on placebo. Among those receiving lebrikizumab, 51 % achieved an EASI-75 response, compared to 18 % taking placebo. Within four weeks, patients receiving lebrikizumab experienced statistically significant improvements in skin clearance and itching, as well as improvements in interference of itch on sleep, and quality of life, as measured by key secondary endpoints. The safety profile of the 16-week period was consistent with prior lebrikizumab studies in AD. Patients taking lebrikizumab, compared to placebo, reported a lower frequency of adverse events in ADvocate 1 (lebrikizumab: 45%, placebo: 52%) and ADvocate 2 (lebrikizumab: 53%, placebo: 66%). Most adverse events across the two studies were mild or moderate in severity and nonserious and did not lead to treatment discontinuation. The most common adverse events in ADvocate 1 and 2 for those on lebrikizumab were conjunctivitis (7% and 8%, respectively), common cold (nasopharyngitis) (4% and 5%, respectively) and headache (3% and 5%, respectively). Detailed 52-week results from ADvocate 1 and 2, as well as 16-week data from ADhere, the Phase 3 AD study of lebrikizumab with topical steroids, will be disclosed in coming months. Lilly and Almirall S.A. plan to submit filings to regulatory authorities around the world by the end of 2022 following completion of the ADvocate studies. Lilly has exclusive rights for development and commercialization of lebrikizumab in the United States and the rest of the world outside Europe. Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.

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