Nemolizumab is a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, a neuroimmune cytokine responsible for driving multiple disease mechanisms in atopic dermatitis and prurigo nodularis.

Galderma’s nemolizumab performed well in three pivotal phase III trials in atopic dermatitis (AD) and prurigo nodularis (PN), according to late-breaking data presented at the 2023 European Academy of Dermatology and Venereology (EADV) congress in Berlin. 

Nemolizumab is a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, a neuroimmune cytokine responsible for driving multiple disease mechanisms in atopic dermatitis and prurigo nodularis.

“Through targeting the neuroimmune cytokine IL-31, these phase III data demonstrate that nemolizumab significantly and quickly improves three of the most burdensome symptoms of these conditions: itch, skin lesions, and sleep disturbance,” says study author Jonathan Silverberg, MD, PhD, MPH, FAAD, Professor, Director of Clinical Research at George Washington University School of Medicine and Health Sciences in Washington, DC, in a news release.

Results from the ARCADIA 1 and 2 trials showed that nemolizumab significantly improved skin lesions and itch in adolescent and adult patients with moderate to severe atopic dermatitis, compared to placebo (both administered with background topical corticosteroid therapy or topical calcineurin inhibitors). In both trials, adolescent and adult patients treated with nemolizumab showed clinically and statistically significant improvements in co-primary endpoints, compared to placebo after 16 weeks of treatment. 

Results across both trials showed that:

• 35.6% and 37.7% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, reached clearance or almost-clearance of skin lesions when assessed using the investigator’s global assessment (IGA) score, compared to 24.6% and 26.0% in the placebo group.
• 43.5% and 42.1% of nemolizumab-treated patients in ARCADIA 1 and 2, respectively, achieved a 75% reduction in the Eczema Area and Severity Index (EASI), compared to 29.0% and 30.2% in the placebo group.

The trials also met all key secondary endpoints, with 48.6% and 48.1% of nemolizumab-treated patients achieving an at least four-point reduction in itch in ARCADIA 1 and 2, respectively, as measured by the peak-pruritus numerical rating scale (PP-NRS) score, compared to 20.5% and 20.6% in the placebo group, within 16 weeks of treatment. Statistically significant results at week 16 and earlier time points also show nemolizumab’s rapid onset of action on itch and sleep disturbance. Nemolizumab was well tolerated, and its safety profile was consistent between the ARCADIA 1 and 2 studies.

In related news, data from the phase III OLYMPIA 1 trial bolstered evidence for nemolizumab’s rapid onset of action on itch and reduction of skin lesions in patients with prurigo nodularis.

In the phase III OLYMPIA 1 trial, nemolizumab as a monotherapy significantly improved itch and skin lesions in adult patients with moderate to severe prurigo nodularis, compared to placebo. Patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically and statistically significant improvements in both primary endpoints, compared to placebo after 16 weeks of treatment, providing independent confirmation of results from the phase III OLYMPIA 2 trial.

The study found that:

• 58.4% of nemolizumab-treated patients achieved an at least four-point reduction in itch, as measured by the PP-NRS score, compared to 16.7% in the placebo group (p<0.0001).
• 26.3% of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the IGA score, compared to 7.3% in the placebo group.

The trial also met all key secondary endpoints confirming rapid onset of action on itch as early as week 4 (41.1% vs. 6.3% in the placebo group), and improvements in itch and skin lesions were observed up to week 24. Nemolizumab was well tolerated, and its safety profile was consistent with OLYMPIA 2 trial results.