Galderma’s nemolizumab shows promise in phase 3 prurigo nodularis trial
06 Jul 2023
Clinical ResultDrug ApprovalPhase 3Breakthrough TherapyPhase 2
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Source: PMLiVE
Galderma has shared positive results from a late-stage study evaluating its investigational monoclonal antibody, nemolizumab, as a monotherapy in adults with moderate-to-severe prurigo nodularis.
Approximately 72 out of every 100,000 adults aged 18 to 64 years in the US are affected by prurigo nodularis, a debilitating chronic skin condition characterised by thick skin nodules covering large body areas and associated with intense itch.
Galderma’s nemolizumab addresses the underlying cause of the disease by inhibiting the activation of the interleukin 31 receptor, a protein implicated in chronic skin conditions such as prurigo nodularis.
According to the latest results from the OLYMPIA 2 trial, which were presented at this year’s World Congress of Dermatology in Singapore, nemolizumab monotherapy was associated with significant improvements in itch, skin clearance, and sleep disturbance compared to placebo.
Its "rapid onset of action" was also highlighted by the results, the company said, with nemolizumab-treated patients experiencing improvement in symptoms as early as week four.
In addition to the data from OLYMPIA 2, Galderma presented the results from two studies it had sponsored on the impact of prurigo nodularis and itch on sleep disturbance.
One study found that patients with the condition have a significantly increased risk of insomnia at one year and of sleep apnea at ten years. The other found that the majority of patients’ sleep disturbances were solely due to itch.
Baldo Scassellati Sforzolini, global head of research and development at Galderma, said: “The itch associated with prurigo nodularis is uniquely intense, causing significant sleep disturbance that substantially reduces quality of life.
"This data demonstrates once again the massive burden those with prurigo nodularis face, and the extent of nemolizumab’s potential to address it.”
Nemolizumab, which is also being assessed as a treatment for atopic dermatitis, was granted Breakthrough Therapy designation by the US Food and Drug Administration in 2019 to treat pruritus (itchy skin) associated with prurigo nodularis. The therapy is approved in Japan for the treatment of pruritus associated with atopic dermatitis.
Sanofi and Regeneron’s Dupixent (dupilumab) was approved by the FDA in September last year as the first and only treatment indicated for prurigo nodularis. The European Commission granted approval to the therapy just over two months later, making it the first targeted medicine specifically indicated for prurigo nodularis in the EU.
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