New late-breaking phase 3 data showed success with nemolizumab, an investigational drug designed for targeting IL-31 signaling and aimed at the underlying causes of the condition.
Nemolizumab monotherapy leads to rapid onset of action in those with prurigo nodularis, according to recent late-breaking data, resulting in a higher percentage achieving an itch-free state by 4 weeks compared to the placebo group.1
This new phase 3 data from the OLYMPIA 2 trial, presented in Singapore at the 25th World Congress of Dermatology (WCD), showed more participants becoming itch-free by 4 weeks compared to placebo.
This was demonstrated by an average peak-pruritus numerical rating scale [PP-NRS] score each week of <2. By 4 weeks, the data indicated that 19.7% in the treatment arm and 2.2% in the placebo arm showed an itch-free rating (P<0.0001).
“The itch associated with prurigo nodularis is uniquely intense, causing significant sleep disturbance that substantially reduces quality of life,” Baldo Scasselati Sforzolini, MD, PhD, the Global Head of Research and Development at Galderma, said in a statement. “These data demonstrate once again the massive burden those with prurigo nodularis face, and the extent of nemolizumab’s potential to address it.”2
These findings are substantial, given that 100% of adults patients with diagnoses of prurigo nodularis reported that intense itch resulting from the disease is their top complaint.
This new study builds upon prior findings with new data that demonstrate a significant increase in the proportion of patients experiencing a meaningful reduction in itch intensity.
Specifically, at week 4, the percentage of those achieving a clinically relevant improvement (a reduction of at least 4 points on the PP-NRS scale) was 5 times higher in the nemolizumab group compared to the placebo group (41.0% compared to 7.7%, P<0.0001).
The drug is a novel monoclonal antibody developed to specifically target IL-31 signaling, which aims to tackle the causes at the root of the skin condition. By directly addressing the itch source, the new research aims to enhance quality of life outcomes including disturbances in sleep.
IL-31 is known to play a crucial role in various disease mechanisms which have been seen in both atopic dermatitis and prurigo nodularis.
Prurigo nodularis is characterized by thick skin nodules that are often found to extensively cover patients’ bodies and the nodules are accompanied by severe itch.
IL-31 is known to act directly on sensory neurons linked with the itch sensation, in addition to contributing to inflammation and disruption of the skin's protective barrier. Thus, IL-31 serves as a link connecting the immune and nervous systems, exerting its effects directly on the structural cells of the skin.
Given the fact that prurigo nodularis affects approximately 72 of every 100,000 adults in the age range of 18 - 64 in the US, the investigational treatment could lead to positive outcomes.3