Galderma has reported new interim analysis data from the OLYMPIA long-term extension trial of monoclonal antibody Nemluvio for the treatment of moderate-to-severe prurigo nodularis (PN), a chronic skin condition marked by thick skin nodules and intense itching.
The data indicate that the antibody is tolerated well and provides sustained improvements in symptoms like skin lesions and itch, for up to two years.
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The OLYMPIA trial involves 508 subjects from earlier Phase II and Phase III OLYMPIA 1 and 2 studies, and aims to evaluate Nemluvio’s efficacy and safety.
Findings at week 100 demonstrate significant symptom improvements, with over 90% and 70% of subjects achieving a minimum four-point improvement in itch and being itch-free or nearly itch-free, respectively. Also, a minimum of 80% show healing of skin lesions.
Subjects also saw clearance or near-clearance of skin nodules, as measured by the Investigator’s Global Assessment score.
Galderma Research & Development global head Baldo Scassellati Sforzolini said: “These promising data go even further in highlighting the extensive benefits of Nemluvio.
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By GlobalData“As this treatment becomes available in more countries around the world, it’s highly encouraging to see its robust evidence base continue to expand and strengthen.”
Nemluvio, targeting the interleukin-31 (IL-31) receptor alpha, claims to be the first and only biologic approved for this condition and atopic dermatitis (AD), offering four-week dosing intervals from treatment onset.
The antibody received US Food and Drug Administration’s (FDA) approval in August 2024 for adults with PN and in December for those aged 12 years and above with moderate-to-severe AD, in conjunction with topical corticosteroids and/or calcineurin inhibitors when the disease is inadequately controlled with topical prescription treatments.
Initially, it was developed by Chugai Pharmaceutical. Galderma acquired exclusive global development and marketing rights for the antibody, excluding Japan, in 2016.
Marketed as Mitchga in Japan, the antibody is approved for PN and pruritus associated with AD in children, adolescents, and the adult population.
Last year, Galderma reported positive data from a Phase III trial of RelabotulinumtoxinA (Relfydess) for treating moderate-to-severe frown lines and crow’s feet.
