Galderma Reports Positive Data from Phase 3 Trial of Nemolizumab in Patients with Rare Skin Condition

Galderma reported that the phase 3 OLYMPIA 2 trial met all primary and key secondary endpoints, showing nemolizumab as monotherapy significantly improved skin lesions and pruritus compared with placebo in adult patients with moderate to severe prurigo nodularis.

Photo: Flemming Ørnskov, CEO of Galderma

Prurigo nodularis is a rare, potentially debilitating, inflammatory skin disease characterized by disfiguring skin nodules often covering extensive areas of the body, and an intense and chronic itch. It affects an estimated 72 per 100,000 adults aged 18-64 years in the United States, primarily middle-aged women and disproportionately people of African descent. There are currently no approved therapeutic options for the condition.

Nemolizumab is a first-in-class investigational monoclonal antibody that blocks the signaling of IL-31, a key neuroimmune cytokine involved in the pathogenesis of prurigo nodularis.

“Prurigo nodularis is known to have a profoundly negative impact on quality of life with currently no approved therapeutic options. These phase 3 trial results indicate that nemolizumab has the potential to be a key therapeutic solution for patients suffering from moderate to severe prurigo nodularis,” said Flemming Ørnskov, CEO of Galderma.

OLYMPIA 2 is a randomized, double-blind, placebo-controlled phase 3 clinical trial, part of the largest clinical program in prurigo nodularis to date aiming to recruit 540 patients, evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of nemolizumab compared with placebo in adult patients with prurigo nodularis after a 16-week treatment period. OLYMPIA 2 includes 274 patients with moderate-to-severe prurigo nodularis.

Patients treated with nemolizumab monotherapy (without background topical corticosteroids or topical calcineurin inhibitors) showed clinically and statistically significant improvement in both primary endpoints compared to placebo after 16 weeks of treatment: 38 percent of nemolizumab-treated patients reached clearance or almost-clearance of skin lesions, when assessed using the investigator’s global assessment (IGA) score, compared to 11 percent in the placebo group; and 56 percent of nemolizumab-treated patients achieved an at least four-point reduction in itch, as measured by the peak-pruritus numerical rating scale (PP-NRS) score, compared to 21 percent in the placebo group.

The trial also met all key secondary endpoints. Data confirm early onset of action on itch, skin lesions and sleep disturbance. Nemolizumab demonstrated a favorable benefit-risk balance in this trial.

A second phase 3 trial investigating the efficacy of nemolizumab in patients with prurigo nodularis, named OLYMPIA 1, is ongoing. The OLYMPIA 1 trial has a similar design to OLYMPIA 2.

Nemolizumab is approved in Japan for pruritus associated with atopic dermatitis and is under 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 and subsequently licensed to Galderma in 2016 worldwide except Japan and Taiwan.

Author: Rare Daily Staff