Eli Lilly reports Ebglyss met primary, secondary endpoints in ADorable-1 study

Eli Lilly (LLY) announced topline results from the Phase 3 ADorable-1 trial evaluating the safety and efficacy of Ebglyss in pediatric patients with moderate-to-severe atopic dermatitis. Ebglyss met the primary and key secondary endpoints at Week 16, improving disease severity while delivering skin clearance and relief from persistent itch. Atopic dermatitis is more common in children than adults, affecting 9.6N children in the U.S., one-third of whom have moderate-to-severe disease. Lilly plans to submit these data to U.S. and global regulators for a potential label update. In ADorable-1, participants were randomized to receive placebo or a weight-based dose of Ebglyss. Topical corticosteroids were required beginning two weeks before randomization and throughout the 16-week study but could be decreased or stopped once patients achieved IGA 2 or less. The co-primary endpoints in ADorable-1 were EASI-75 and IGA 0,1 at Week 16. Key secondary endpoints included an even greater clinical improvement in disease severity and itch relief. Additional results from ADorable-1 and ADorable-2, a 52-week extension study of patients enrolled in ADorable-1, will be disclosed later this year.