Eli Lilly and Company announced positive, topline results from the phase-III ADorable-1 trial evaluating the safety and efficacy of EBGLYSS (lebrikizumab-lbkz) in paediatric 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 9.6 million children in the US, one-third of whom have moderate-to-severe disease. Lilly plans to submit these data to US and global regulators for a potential label update.

EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity and slow dissociation rate. The cytokine IL-13 is a primary cytokine in atopic dermatitis, driving the type-II inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.

In ADorable-1, participants were randomised to receive placebo or a weight-based dose of EBGLYSS. Topical corticosteroids were required beginning two weeks before randomisation 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 (EASI-90) and itch relief (Pruritus NRS ≥4-point improvement).

Children with moderate-to-severe atopic dermatitis often endure relentless skin flares, itch and discomfort that can disrupt play, school and daily life for patients and caregivers. EBGLYSS has already changed what's possible for adults and adolescents, delivering durable results that help patients flare less with the option of monthly maintenance dosing. Now, these data show EBGLYSS also provided disease control in paediatric patients, a critical milestone that, if approved, could bring profound relief to these patients and their families," said Adrienne Brown, Executive Vice President and President, Lilly Immunology.

The safety of EBGLYSS was consistent with the known profile in adult and adolescent patients, with no new safety signals observed. The most common adverse events occurring in ≥5 percent of participants were upper respiratory tract infections and nasopharyngitis, with no numerical imbalance between treatment groups. Injection site reactions were reported similarly in the EBGLYSS and placebo arms, with no injection site pain reported.

"Despite the high prevalence of moderate-to-severe atopic dermatitis in infants and young children, they have fewer approved treatment options than adults and adolescents," said Amy Paller, MD, Chair, Department of Dermatology, Northwestern University and ADorable study investigator. The topline results from ADorable-1 offer hope for these young patients, delivering near-complete skin clearance and significant itch relief with a highly selective medicine that targets the underlying inflammation that drives this chronic disease."

The ADorable clinical programme is ongoing. 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.