Galderma reveals positive late-stage results for nemolizumab in treating prurigo nodularis

Galderma’s nemolizumab has demonstrated considerable efficacy in improving the core signs and symptoms of prurigo nodularis according to results from a Phase 3 trial. This chronic skin condition, known for causing severe itch and thick skin nodules, impacts up to 181,000 individuals in the United States.

The study, known as the 24-week OLYMPIA 1 trial, was conducted to assess the efficacy and safety of nemolizumab as a standalone treatment in adult patients with moderate-to-severe prurigo nodularis. The trial achieved both its primary and all key secondary endpoints. Patients treated with nemolizumab experienced significantly higher improvements in itching and skin lesions compared to those who received a placebo by week 16. Notably, clinically meaningful responses in itch reduction and sleep disturbance were observed as early as week four.

At the 16-week mark, 58.4% of patients who were administered nemolizumab reported at least a four-point improvement in itch intensity. In contrast, only 16.7% of patients in the placebo group reported similar improvements. Additionally, 26.3% of nemolizumab-treated patients achieved clearance or near-clearance of skin lesions, compared to just 7.3% of patients in the placebo group.

Prurigo nodularis, characterized by intense itch and extensive skin nodules, has been a challenging condition to manage. Nemluvio, the brand name under which nemolizumab is marketed, aims to tackle the root cause of the disease by inhibiting the signaling of the neuroimmune cytokine IL-31.

The recent publication of these findings in JAMA Dermatology follows the approval of nemolizumab by the US Food and Drug Administration (FDA) three months prior. The FDA’s approval decision was based on the positive outcomes from both the OLYMPIA 1 and OLYMPIA 2 Phase 3 trials, the latter also highlighting rapid and significant improvements in itch and skin lesions in patients treated with nemolizumab.

Currently, Galderma has submitted marketing authorization applications for nemolizumab for the treatment of prurigo nodularis and atopic dermatitis to multiple regulatory authorities, including the European Medicines Agency. These applications are under review.

In a recent statement, Baldo Scassellati Sforzolini, global head of research and development at Galderma, emphasized the significance of the trial results. He highlighted the potential for this treatment to provide rapid and substantial relief from the most problematic symptom of prurigo nodularis – itch. Sforzolini reiterated the company's commitment to making this treatment option accessible to patients worldwide as quickly as possible.