Galderma Presents New EADV Nemolizumab Data Strengthening Rapid Onset and Consistent Symptom Relief in People With Prurigo Nodularis and Atopic Dermatitis

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LAUSANNE, Switzerland – (COMMERCIAL THREAD) – Galderma today announced the presentation of new Phase 2 data supporting the efficacy of its investigational monoclonal antibody, nemolizumab, at 30e EADV Congress, taking place from September 28 to October 2, 2021.

Results from two key trials with nemolizumab given every 4 weeks demonstrate rapid onset of action and significant reduction in symptoms in patients with lumpy prurigo (PN) and atopic dermatitis (AD), and new concrete evidence highlight the burden of PN.

“We are excited to share new analyzes and clinical trial data that enhance the therapeutic potential of nemolizumab and its full benefits against prurigo nodularis and atopic dermatitis. There is increasing scientific evidence for the critical role the IL-31 pathway plays in the inflammatory process and we are committed to continuing our work diligently to bring nemolizumab to patients living with these debilitating skin conditions. ”

BALDO SCASSELLATI SFORZOLINI, MD, PH.D., GLOBAL R&D MANAGER, GALDERMA

Nemolizumab dramatically reduces itching within 48 hours in PN

The results of a secondary analysis of a phase 2 trial evaluating onset of action in pruritus and sleep disturbances in patients with moderate to severe PN were the subject of Abstract No. 465. In 48 hours, nemolizumab significantly reduced severe itching more than three times more effectively than placebo (-19.5% vs -5.8%, respectively, p = 0.014), a rapid and significant decrease in itching that continued maintained for the duration of the study. By day 4, about a quarter of patients already had a strong reduction in severe itchy responses to nemolizumab treatment, compared to no response for the placebo group (23.5% vs. 0%, p

On day 4, nemolizumab resulted in a four-fold improvement in sleep disturbances compared to placebo (-19.8% vs. -4.3%, p = 0.012), with significantly increased benefits through week 4.

“Prurigo nodularis is associated with markedly impaired quality of life and frequent sleep deprivation. This analysis demonstrates the rapid onset of action of nemolizumab resulting in reduction of itching within 48 hours of the first dose, and significant improvement in sleep from day 4 for moderately to severely affected patients. This symptomatic relief translates into a significant improvement in the daily life of these patients. ”

PROFESSOR SONJA STÄNDER PRINCIPAL RESEARCHER, PROFESSOR OF DERMATOLOGY, MUENSTER UNIVERSITY HOSPITAL, MUENSTER, GERMANY

Suggested direct anti-inflammatory effect for nemolizumab leading to early improvement in AD

New and consistent results for nemolizumab in AD were also presented in Abstract # 1200, a secondary post-hoc analysis of phase 2b data in adult patients with moderate to severe AD recently published in the Journal of Allergy. and Clinical Immunology (JACI). From the first week of treatment, nemolizumab showed significant improvement in clinical signs and symptoms of AD, as indicated by SCORAD, increasing through week 16. This included early improvement in erythema and excoriation. suggests a direct anti-inflammatory effect, while an improvement in dryness vs placebo skin could be a consequence of a beneficial effect of nemolizumab on the skin barrier.

“This analysis is important because it highlights the direct anti-inflammatory effect of nemolizumab and strengthens our understanding of its mechanism of action, resulting in a rapid and profound reduction in itching sensations and skin lesions in patients living with dermatitis. atopic.

PROFESSOR JEAN-DAVID BOUAZIZ SENIOR INVESTIGATOR, DEPARTMENT OF DERMATOLOGY, HPITAL SAINT-LOUIS, PARIS, FRANCE

Marked improvements in signs and symptoms of AD have also been demonstrated in adolescent patients

A third abstract, No. 976, reviewed the pharmacokinetics (PK), safety, and efficacy during treatment with nemolizumab for AD in adolescents. AD is problematic in this age group because many activities in a teen’s daily routine, such as sports and extracurricular activities, lead to an increase in body temperature and sweating. Additionally, as academic and social pressures increase during adolescence, anxiety and stress levels increase, worsening the symptoms of AD. In patients aged 12 to 17 years with moderate to severe pruritus, nemolizumab has shown marked improvement in rash, itching, sleep, quality of life (QoL) and biomarkers.

About atopic dermatitis

Atopic dermatitis (AD) is a disruptive and debilitating inflammatory skin disease characterized by diffuse skin lesions and constant disruptive itching.1.2 The reported prevalence of AD varies widely, ranging from 1% to 25% of the population depending on geography and age group.3 This serious and chronic skin disease can have a profound impact on the quality of life of patients, leading to sleep disturbances and causing secondary skin infections.4

About prurigo nodularis

Prurigo nodularis (PN) is a rare, potentially debilitating, chronic skin condition with thick skin lumps covering large areas of the body and associated intense and persistent itching.5 Although PN can occur at any age, it is more likely to affect people between the ages of 40 and 69, frequently leading to a serious deterioration in quality of life.4

The global prevalence of PN is unknown because there are no studies describing the epidemiology of the disease. In the United States, the latest estimate is that PN affects 52.9 people in 100,000.4 In the European context, rates between 0.65 and 11.1 per 10,000 inhabitants have been reported. In addition to natural variation, this relatively wide range of estimates is in part due to differences in the definition of cases and the representativeness of the populations studied.6

About nemolizumab

Nemolizumab is a first-class monoclonal antibody directed against the IL-31 alpha receptor which blocks signaling of the neuroimmune cytokine IL-31.7 IL-31 plays a key role in multiple pathological mechanisms in atopic dermatitis and prurigo nodularis. With its unique role in directly stimulating itch-related sensory neurons and contributing to inflammation and barrier dysfunction, IL-31 is a central mediator that serves as a bridge between the immune and nervous systems while acting directly on the structural cells of the skin. Nemolizumab, originally developed by Chugai Pharmaceutical Co., Ltd., was later licensed to Galderma in 2016 – worldwide except Japan and Taiwan. Nemolizumab is an investigational agent in clinical development for the treatment of atopic dermatitis and prurigo nodularis and its safety and efficacy have not been fully evaluated by any regulatory authority. Nemolizumab was granted breakthrough therapy designation by the United States Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis.

About Galderma

Galderma, the world’s largest independent dermatology company, was established in 1981 and is now present in over 100 countries with an extensive portfolio of prescription drug products, cosmetic solutions and consumer care products. The company partners with healthcare practitioners around the world to meet the skin health needs of people throughout their lives. Galderma is a leader in the research and development of scientifically defined and medically proven skin solutions. For more information, please visit www.galderma.com

The references

1 Langan S. et al. Atopic dermatitis. The Lancet. 2020; 396 (10247): 345-360. DOI: https://doi.org/10.1016/S0140-6736(20)31286-1

2 Weidinger S. et al. Atopic dermatitis. Nature notice. 2018. DOI: 10.1038 / s41572-018-0001-z

3 Silverberg, J, I. Public health burden and epidemiology of atopic dermatitis. 283-289. 2017.

4 Atopic eczema – Symptoms. NHS. Available at: https://www.nhs.uk/conditions/atopic-eczema/symptoms/ Accessed: March 2021

5 Galderma. Data on file.

6 Morgan LI. Christophe. Epidemiology of prurigo nodularis in England. 2021.

7 Saleem M. et al. Interleukin-31 pathway and its role in atopic dermatitis: a systematic review. J Dermatological treatment. 2017; 28 (7): 591-599. DOI: 10.1080 / 09546634.2017.1290205


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