The first IL-31 receptor blocking antibody! Nemolizumab treatment of pruritus nodosa (PN) stage II clinical significantly reduced the degree of pruritus!

February 23, 2020 / Biovalley BIOON / -- Galderma is the world's largest independent global dermatology company and the leader in research and development of scientifically defined and medically proven dermatology solutions Recently, the company announced that the complete results of the phase II study (nct03181503) on the treatment of moderate to severe prurigo nodulis (PN) by nemolizumab have been published in the New England Journal of Medicine (NEJM) Article title: trial of nemolizumab in moderate to severe prurigo nodularis PN is a kind of chronic pruritus skin disease with multiple nodular lesions It is a rare and potentially aging chronic skin disease Thick skin nodules cover a large area of the body and are related to severe pruritus The disease often leads to serious quality of life damage Nemolizumab is a first-in-class monoclonal antibody, which can target and bind to interleukin-31 receptor (il-31r) and block IL-31 signaling IL-31 is a cytokine that induces pruritus, and its signal transduction plays a key role in the pathogenesis of PN In November 2019, the U.S Food and Drug Administration (FDA) has granted nemolizumab a breakthrough drug qualification (BTD) for the treatment of PN related pruritus Galderma is actively preparing to launch the key phase III project of nemolizumab single drug treatment for adult PN patients in 2020 The study, published on NEJM, was a randomized, double-blind, placebo-controlled, parallel group, multicenter, 12 week phase II study involving 70 adults with moderate to severe PN and severe pruritus In the study, from baseline to week 8, patients were randomly assigned to receive a weekly subcutaneous injection of nemolizumab (dose: 0.5mg/kg body weight) or placebo, once in week 0 (baseline), once in week 4, and once in week 8 In this study, moderate to severe nodular pruritus was defined as having 20 or more nodules, and severe pruritus was defined as having an average score of at least 7 for the daily intensity of the most severe pruritus on the numerical scale (score range: 0 [no pruritus] to 10 [the most severe pruritus imaginable]) The results showed that the study reached the primary end point: from baseline to week 4, the nemolizumab treatment group's peak pruritus Rating Scale (pp-nrs) score was significantly lower than that of the placebo group The baseline pp-nrs score of the two groups was 8.4 At the 4th week, the P p-nrs score of nemolizumab treatment group was 4.5 points lower than that of baseline (change: - 53.0%), and that of placebo group was 1.7 points lower (change: - 20.2%), with statistically significant difference (difference: - 32.8%; 95% CI: - 46.8 to - 18.8, P < 0.001) In addition, in all other indicators, the nemolizumab treatment group showed significant differences At the 18th week (10 weeks after the last administration), 38% of the patients in the nemolizumab treatment group completely or almost completely removed PN, compared with 6% in the placebo group (P = 0.001) In the study, nemolizumab was well tolerated and no adverse event imbalance was observed between the two groups Nemolizumab therapy is associated with gastrointestinal symptoms (abdominal pain and diarrhea) and musculoskeletal symptoms Dr Thibaud portal, global head of prescription drugs at Galderma, said: "it is well known that prurigo nodosa has a serious negative impact on the quality of life of patients Although there are a large number of unmet needs, there is currently no registered treatment plan The results of this phase II study suggest that nemolizumab may play a key role in patients with moderate to severe prurigo nodosa We are committed to further testing the drug in phase III studies and are determined to provide solutions for patients with prurigo nodosa " Nemolizumab is a humanized monoclonal antibody, targeting to block IL-31 receptor A, which is believed to inhibit the biological activity of IL-31 by competitively blocking the binding between IL-31 and its receptor Nemolizumab is developed by Chinese and foreign pharmaceutical companies In 2016, Galderma acquired nemolizumab's global (except Japan and Taiwan) rights from Chinese and foreign pharmaceutical licensing Nemolizumab was created by act Ig, a proprietary antibody engineering technology of Chinese and foreign pharmaceutical, which can extend the biological half-life of antibody in blood Source: gallerma announcements New England Journal of medicine publication from phase 2 study of investigative therapy neurolizumab in patients with moderate to severe prurigo Nodularis