Galderma has announced full results from its Phase II study of nemolizumab in adult patients suffering from moderate-to-severe prurigo nodularis (PN).
The investigational therapy works by blocking signalling of IL-31 that play a key role in the pathogenesis of PN, and was initially developed by Chugai before being licensed to Galderma.
In the study, the company confirmed that the drug met the primary endpoint of a greater improvement in Peak Pruritus Numerical rating scale (PP-NRS) from baseline to week four compared to placebo, and that at week 18 (10 weeks after the last dose), 38% of the patients who received nemolizumab were clear or almost clear of PN compared to 6% of the patients who received placebo.
The data, published in The New England Journal of Medicine (NEJM), “brings important attention to prurigo nodularis, where it has been very challenging for clinicians to take care of their patients in the absence of any registered therapy targeting prurigo nodularis” said Sonja Ständer, center for chronic pruritus, department of dermatology, University of Münster, Germany and lead author of the NEJM paper.
“We are encouraged by the consistent findings across this study and look forward to further clinical investigation with nemolizumab.”
Dr Thibaud Portal, global head of prescription medicines at Galderma, also commented: “Prurigo nodularis is known to have a profoundly negative impact on quality of life of patients”, and reminded that “despite significant unmet needs, there are currently no registered therapeutic options.”
He continued, “The Phase II study results indicate that nemolizumab may have a key role to play for patients with moderate to severe prurigo nodularis. We are fully committed to test this drug further in Phase III studies and determined to bring solutions for patients suffering from prurigo nodularis.”
PN is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus.