Galderma's nemolizumab is a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, widely recognized as the itch cytokine and a central mediator of inflammation and fibrosis in prurigo nodularis.

Nemolizumab monotherapy quickly tames itch in Prurigo Nodularis, according to a late-breaking late-breaking Phase III study presented at the 25th World Congress of Dermatology (WCD) in Singapore.

Fully 19.7% of patients treated with nemolizumab monotherapy achieved an itch-free state as early as week 4 after only one dose of nemolizumab, the study showed. The new data expand upon those previously reported, namely a fivefold increase in the number of patients who achieved a clinically relevant improvement in itch intensity (PP-NRS reduction ≥ 4 points) at week 4 (41.0% for nemolizumab vs. 7.7% for placebo, p<0.0001).

Nemolizumab is a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, widely recognized as the itch cytokine and a central mediator of inflammation and fibrosis in prurigo nodularis.

The OLYMPIA 2 trial evaluated the efficacy, safety, pharmacokinetics and immunogenicity of nemolizumab compared with placebo in adult patients with moderate to severe prurigo nodularis. Topline data were presented to the scientific community earlier this year at the American Academy of Dermatology (AAD). The study met all primary and secondary endpoints, demonstrating that nemolizumab monotherapy significantly improved itch, skin clearance and sleep disturbance. The rapid onset of action was also highlighted, with patients experiencing improvement in itch, sleep intensity and skin clearance as early as week 4. The safety profile was consistent with the phase II results.3

Galderma also presented the results of two Galderma-sponsored studies on the significant impact of prurigo nodularis and itch on sleep disturbance at WCD. In a retrospective, population-level, matched-cohort study, patients with prurigo nodularis were found to have a significantly increased risk of insomnia at one year and of sleep apnea at 10 years. In a qualitative study designed to understand how patients experience sleep disturbance related to prurigo nodularis, the majority (71%) reported that their sleep disturbance was solely due to itch.

Data from OLYMPIA 2, also presented at AAD, showed that nearly four times as many patients treated with nemolizumab achieved a significant and clinically meaningful improvement in sleep disturbance, measured by a 4-point improvement on the sleep disturbance numerical rating scale (SD-NRS; 37.2% for nemolizumab vs. 9.9% for placebo p<0.0001).

Nemolizumab is in clinical development for the treatment of atopic dermatitis and prurigo nodularis in many countries around the world. Nemolizumab was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis. It was initially developed by Chugai Pharmaceutical Co., Ltd., and subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. In Japan, nemolizumab is approved for the treatment of pruritus associated with atopic dermatitis and is in development for prurigo nodularis.