ZUG, SWITZERLAND -- Galderma (SIX: GALD) announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.[1] Results will be presented in a late-breaking session at the 2026 American Academy of Dermatology (AAD) Annual Meeting.

Atopic dermatitis is the most common inflammatory skin disorder in children, yet treatment options in the moderate-to-severe pediatric setting are limited.[5] The disease can have a significant impact on quality of life for both the patients and their loved ones, with persistent itch and recurrent skin lesions often disrupting sleep, school and relationships.[5-8]

“Atopic dermatitis can affect many aspects of children’s lives including schoolwork, emotional development, and social confidence. This burden also often extends to caregivers who can experience anxiety, stress, and sleep loss. In our study, nemolizumab demonstrated a clinically meaningful benefit in children with moderate-to-severe atopic dermatitis, helping to reduce skin lesions and itch up to one year, and had a similar safety profile as with adults and adolescents.”

LAWRENCE EICHENFIELD, M.D.
PROFESSOR OF DERMATOLOGY AND PEDIATRICS AT THE UNIVERSITY OF CALIFORNIA SAN DIEGO SCHOOL OF MEDICINE AND CHIEF OF PEDIATRIC DERMATOLOGY AT RADY CHILDREN'S HOSPITAL SAN DIEGO, UNITED STATES

Clinically meaningful reductions in skin lesions and itch in children with atopic dermatitis
A phase II study (NCT04921345) was conducted to assess the pharmacokinetics, safety, and efficacy of nemolizumab in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis.[1] Results showed that nemolizumab pediatric doses were associated with similar pharmacokinetic exposure compared to adults and adolescents, and were well tolerated and effective in children, with clinically meaningful reductions in skin lesions and itch through Week 16 and sustained up to Week 52.[1] Amongst two of the cohorts evaluated, children aged 7 to 11 and 2 to 6, with nemolizumab doses of 5 mg (for weights ≥10 kg to <20 kg), 10 mg (for ≥20 kg to <30 kg), and 15 mg (for ≥30 kg):

· Investigator’s Global Assessment of skin lesion improvement to clear (0) or almost clear (1) skin was observed as early as Week 4, with 41-47% of patients achieving it by Week 16[1]
· A 75% improvement in the Eczema Area and Severity Index score was observed as early as Week 4, with 69-73% of patients achieving it by Week 16[1]
· Itch relief - defined as a score of ≥4 on the Peak Pruritus Numerical Rating Scale (PP-NRS) - was observed as early as Week 1, with 72% of children aged 2 to 6 and 59% of children aged 7 to 11 achieving it at Week 16[1]
· Similar or higher response rates were observed at Week 52 for all these clinical endpoints demonstrating sustained efficacy over a year[1]

These phase II findings are consistent with the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis.[2,3]

“These new data in children below 12 years old build on nemolizumab’s robust and growing clinical evidence base in moderate-to-severe atopic dermatitis. They also demonstrate our commitment to advancing research to address key areas of unmet need in dermatology, such as atopic dermatitis in children, which has such a high prevalence and burden.”

CHRISTOPHE PIKETTY, M.D., PH.D.
GLOBAL PROGRAM HEAD, THERAPEUTIC DERMATOLOGY
GALDERMA