ZUG, SWITZERLAND -- Galderma (SIX: GALD) announced two-year data from a new interim analysis of a long-term extension study investigating the safety and efficacy of Nemluvio in moderate-to-severe atopic dermatitis. The data show that Nemluvio is well tolerated, with no new safety signals identified, reinforcing its rapid onset of action and demonstrating sustained and increased improvements in symptoms including itch and skin lesions with prolonged treatment up to two years.[1] These data will be presented in a late-breaker abstract at the Revolutionizing Atopic Dermatitis (RAD) Conference, taking place from June 6-7, 2025.

“With Nemluvio now being launched in several countries, it’s so encouraging that we continue to see its robust evidence base expand. Long-term data is pivotal to this, highlighting the profound impact this innovative treatment can have in atopic dermatitis well into the future.”

BALDO SCASSELLATI SFORZOLINI, M.D., PHD.
GLOBAL HEAD OF RESEARCH & DEVELOPMENT
GALDERMA

Atopic dermatitis affects more than 230 million people worldwide.[3] Often reported as one of patients’ most problematic symptoms, 87% of people with atopic dermatitis say they are seeking freedom from itch, with speed of itch relief therefore also prioritized by both patients and physicians.[4-7] Nemluvio is the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31.[3], [8], [9] IL-31 is a neuroimmune cytokine that drives itch and is involved in inflammation and skin barrier dysfunction in atopic dermatitis.8,10 Nemluvio is also the first and only biologic approved for atopic dermatitis as well as prurigo nodularis with four-week dosing intervals from the start of treatment, and the only option to move to eight-week dosing intervals for appropriate patients with atopic dermatitis.[9]

“The relentless itch of atopic dermatitis is not just a symptom; it's a constant burden that disrupts sleep, concentration, and the simple joys of life. Nemolizumab has demonstrated its impact on both itch and skin lesions in atopic dermatitis extensively over the years, and these new data, demonstrating its benefit up to two years, add another layer of confidence to that.”

PROFESSOR JONATHAN SILVERBERG
LEAD INVESTIGATOR OF THE ARCADIA CLINICAL PROGRAM, PROFESSOR OF DERMATOLOGY, GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES, UNITED STATES

The ARCADIA long-term extension study was designed to assess the long-term safety and efficacy of Nemluvio in patients with moderate-to-severe atopic dermatitis up to five years and includes more than 1,900 patients who either completed the initial or maintenance period in ARCADIA 1 or 2, a previous phase II/IIIb study, or were newly enrolled adolescent patients.[1]

Results to be presented at the RAD Conference will show that Nemluvio is associated with sustained and increased improvements in skin lesions, itch, sleep, and quality of life during prolonged treatment up to two years.[1] At week 104 in evaluable patients, the interim analysis shows that:

· More than 85% achieved a 75% reduction in the Eczema Area and Severity Index (EASI)[1]
· Approximately 85% and 70% achieved an at least four-point improvement in itch, and being itch free or nearly itch free, respectively, when assessed using the SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) Pruritus score. Improvements in sleep mirrored those in itch[1]
· Approximately 60% reached clearance or almost-clearance of skin lesions when assessed using the Investigator’s Global Assessment (IGA) score[1]
· Patients’ quality of life improved over time, as measured by the Dermatology Life Quality Index (DLQI)[1]

Results also reinforce Nemluvio’s rapid onset of action on itch and skin at Week 4, with 49% of patients who entered the long-term extension study naïve to Nemluvio achieving a 75% reduction in the EASI, and 69% achieving an at least four-point improvement in itch when assessed using the SCORAD VAS Pruritus score.[1]

Nemluvio was well tolerated in the long-term treatment of atopic dermatitis and no new safety signals were identified.[1]

Additional data from both the ARCADIA program in atopic dermatitis, as well as from the OLYMPIA open-label extension study in prurigo nodularis will be presented at RAD 2025, reinforcing Nemluvio’s rapid impact on key symptoms of atopic dermatitis, and its long-term efficacy in prurigo nodularis.[11], [12]