Galderma announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to nemolizumab for the treatment of pruritus associated with prurigo nodularis.
Breakthrough Designation was based on the results of a phase 2 trial in which 70 patients with prurigo nodularis were randomized to subcutaneous nemolizumab at 0.5 mg/kg or placebo at weeks 0, 4, and 8, then followed off therapy out to week 18. The primary endpoint was the percentage decrease in the peak pruritus score from baseline to week 4, at which point they had only received one dose. The nemolizumab group averaged a 53.4% reduction, compared with 15.3% in placebo-treated controls. At week 12, a full month after the final injection, the split was 63.2% versus 20.2%. And at week 18, the nemolizumab group maintained a mean 58.2% reduction from baseline versus 20.9% in controls.
Galderma is now actively preparing for the initiation of a Phase 3 pivotal program with nemolizumab in adult patients with prurigo nodularis in 2020.
Therapies that are granted Breakthrough Therapy Designation by the U.S. FDA target serious or life-threatening diseases or conditions and provide preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
Nemolizumab is a humanized monoclonal antibody directed against the IL-31 receptor alpha, which blocks signaling from IL-31.
Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd., and was subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan.
About Prurigo nodularis
Prurigo nodularis is a skin disease that causes hard, itchy lumps (nodules) to form on the skin. The itching (pruritus) can be intense, causing people to scratch themselves to the point of bleeding or pain. Scratching can cause more skin lesions to appear. The exact cause of PN is unknown. Diagnosis of the disease is based on observing signs such as extremely itchy skin with the formation of nodules. In some cases, a skin biopsy is used to confirm the diagnosis. Treatment may include corticosteroid creams, oral medications, cryotherapy, or photochemotherapy.