Eli Lilly and Company (NYSE:LLY) on Monday announced positive topline results from the Phase 3 ADorable-1 trial evaluating EBGLYSS (lebrikizumab-lbkz) in patients aged six months to 18 years with moderate-to-severe atopic dermatitis.
At Week 16, EBGLYSS achieved an EASI-75 response rate of 63%, an IGA score of 0 or 1 (clear or almost clear) in 44%, EASI-90 in 39% and improvement of at least 4 points on the Pruritus Numeric Rating Scale in 35% of patients.
The safety profile was consistent with data from adult and adolescent studies, with no new safety signals observed and no reports of injection site pain.
Lilly plans to pursue regulatory submissions for potential updates to the EBGLYSS label to include pediatric patients, building on its existing approvals for adolescents and adults with moderate-to-severe atopic dermatitis.
The ADorable program, which includes multiple studies in pediatric populations, and a 52-week extension trial remain ongoing.
The results add to the growing body of evidence supporting EBGLYSS, a selective IL-13 inhibitor, as a potential treatment option for younger patients with this chronic inflammatory skin condition.