Galderma Group AG (GDERF,GALD.SW), a dermatology company, on Tuesday released new clinical findings confirming that Nemluvio showed significant relief of itch and sleep disturbances within 48 hours in patients with atopic dermatitis and prurigo nodularis.
The findings from post-hoc analyses of the phase III ARCADIA and OLYMPIA clinical trial programs were published in the Journal of the European Academy of Dermatology and Venereology.
Atopic dermatitis (AD) and prurigo nodularis (PN) are chronic dermatological conditions characterised by severe itching and eczematous lesions, including papules and nodules.
The relevant analyses focused on data from the ARCADIA 1 and 2 trials in atopic dermatitis and the OLYMPIA 1 and 2 trials in prurigo nodularis, from participants who reported itch intensity and sleep disturbance. Daily assessments were done with Peak Pruritus Numerical Rating Scale (PP-NRS) and Sleep Disturbance Numerical Rating Scale (SD-NRS).
The OLYMPIA program included two identically designed pivotal phase III clinical trials, OLYMPIA 1 and OLYMPIA 2, for evaluating the efficacy and safety of nemolizumab monotherapy against placebo in adults above 18 years with moderate-to-severe prurigo nodularis, over 16 and 24 weeks of treatment, and enrolled 560 patients.
The ARCADIA program included two identically designed, pivotal phase III clinical trials, which enrolled more than 1,700 patients - ARCADIA 1 and ARCADIA 2 for evaluating the efficacy and safety of nemolizumab administered subcutaneously every four weeks compared to placebo both administered with background topical corticosteroids with or without topical calcineurin inhibitors on adolescent and adult patients 12 years and over with moderate-to-severe atopic dermatitis for an initial treatment phase of 16 weeks.
The findings showed that, Nemolizumab reduced itch within 2 days in atopic dermatitis by about 10.7% in nemolizumab-treated patients, compared with 2.9% in placebo-treated patients. And in prurigo nodularis, the itch was reduced by 17.2% treated with nemolizumab compared to 3.7%.
Nemolizumab improved sleep disturbance within 2 days in atopic dermatitis by approximately 9.9%, compared with 4.6% with placebo. And for prurigo nodularis, nemolizumab treatment improved sleep disturbance by 13.4% compared to 4.3% of placebo.
The study also demonstrated that by Day 14, a quarter of patients with atopic dermatitis and more than a third of patients with prurigo nodularis were said to have achieved significant and clinically meaningful responses in both itch and sleep outcomes.
Significant PP-NRS responses were observed on Day 2, when taken individually, in each study, as reported.
Nemluvio was approved in the US for the treatment of adults with prurigo nodularis in August 2024 and for patients 12 years and older with moderate-to-severe atopic dermatitis in December 2024.
Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. Galderma currently holds the exclusive rights to develop and market nemolizumab in the US, Europe, and other regions worldwide, excluding Japan and Taiwan, under the brand name Nemluvio. In Japan and Taiwan, the drug is marketed by Maruho Co., Ltd. under the brand name Mitchga.
Net sales of Nemluvio for the first nine months of 2025 were $263 million. Earlier this October, with a significant ramp-up of Nemluvio expected, Galderma raised full-year guidance in its recent report to 17.0-17.7% from an earlier projected 12-14%.
GALDERMA GROUP shares are trading 0.93% lower at 160.50 Swiss francs.
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