When Galderma assessed itching via a weekly average peak-pruritus numerical rating scale, it found more patients reached an itch-free state by week four than placebo. Nearly 20% of patients reached an earlier itch-free state compared to 2.2% of patients from the placebo group.
Galderma also reported results from a sponsored-sleep trial that demonstrated patients administered nemolizumab had reduced sleep disturbance. Sleep disturbance is a common consequence of prurigo nodularis due to itch intensity.
The Phase III trial (NCT04501666), called OLYMPIA 2, evaluated the efficacy, safety, pharmacokinetics, and immunogenicity of nemolizumab compared with placebo in adult patients with prurigo nodularis. Patients were administered 30 mg of Galderma’s nemolizumab candidate (CD14152), with itching and severity of prurigo nodularis assessed after 16 weeks as the two primary endpoints. According to the trial’s entry on ClinicalTrials.gov, 286 participants were enrolled across global study centres.
The results consolidate topline data reported in 2022, demonstrating the trial met primary and secondary endpoints.
A monoclonal antibody targeting the interleukin (IL)-31 receptor alpha, nemolizumab was approved in Japan in early 2022 for the treatment of atopic dermatitis where other treatments are ineffective. It is marketed as Mitchga Syringes and made by Maruho. Galderma received global licensing rights to the drug in 2016, except for Japan and Taiwan.
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Galderma’s global head of R&D Dr Baldo Scassellati Sforzolini said: “The itch associated with prurigo nodularis is uniquely intense, causing significant sleep disturbance that substantially reduces quality of life. These data demonstrate once again the massive burden those with prurigo nodularis face, and the extent of nemolizumab’s potential to address it.”