New detailed results from Eli Lilly and Company's Phase 3 monotherapy studies in atopic dermatitis (AD) showed investigational lebrikizumab provided robust and durable improvements in skin clearance and itch for patients who achieved a clinical response at Week 16 through one year of treatment. Lebrikizumab, a high-affinity and potent IL-13 inhibitor, delivered similar results when dosed once every four weeks or once every two weeks after Week 16. These data were featured in a late-breaking, oral presentation at the 31stáEuropean Academy of Dermatology and Venerology (EADV) Congress.

The company previously announced topline results of these one-year analyses of ADvocate 1 and ADvocate 2 in June 2022.áSafety among patients at 52 weeks was consistent with the induction phase of the trials and prior lebrikizumab studies in AD. The incidence rate of treatment-emergent adverse events remained stable over time in patients with lebrikizumab. The proportion of lebrikizumab-treated patients who reported an adverse event in ADvocate 1 and ADvocate 2 through Week 52 was 58% and 68%, respectively.

Most adverse events across the two studies were mild or moderate in severity, nonserious and did not lead to treatment discontinuation. The most commonly reported adverse events were conjunctivitis, common cold and headache. Full results from the Phase 3 studies will be published in a peer-reviewed journal.

Lilly and Almirall S.A. plan to submit regulatory applications to U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) respectively for lebrikizumab in AD this year. The FDA granted lebrikizumab Fast Track designation in AD in December 2019.