Galderma presents new nemolizumab data at EADV that enhances the rapid onset of action and consistent symptom relief in people with prurigo nodularis and atopic dermatitis

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LAUSANNE, Switzerland – (BUSINESS WIRE) – Galderma today announced the presentation of new Phase 2 data demonstrating the efficacy of its investigational monoclonal antibody nemolizumab for the virtual 30th timeNS EADV Congress, which will take place from September 28th to October 2nd, 2021.

The results of two major studies with nemolizumab given every 4 weeks show a rapid onset of action and a significant reduction in symptoms in patients with prurigo nodularis (PN) and atopic dermatitis (AD), and new real-world evidence supports PN – burden of disease.

“We are pleased to announce new analysis and clinical trial data that support the therapeutic potential and extensive benefits of nemolizumab in prurigo nodularis and atopic dermatitis. The scientific evidence of the critical role that the IL-31 signaling pathway plays in the inflammatory process is growing, and we strive to consistently continue our work to make nemolizumab available to patients with these debilitating skin conditions. ”

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

Nemolizumab significantly reduces itching within 48 hours in PN

The results of a secondary analysis of a phase 2 study investigating the onset of action on pruritus and sleep disorders in patients with moderate to severe PN were the subject of abstract # 465. Within 48 hours, nemolizumab was significantly three times as effective at reducing severe itching as placebo (-19.5% and -5.8%, p = 0.014), a rapid and significant decrease in itching that was sustained for the duration of the study. On day 4, around a quarter of the patients already showed a strong reduction in the response to severe itching to treatment with nemolizumab compared to no response in the placebo group (23.5% vs. 0%, p

On day 4, nemolizumab resulted in a four times greater improvement in sleep disorders compared to placebo (-19.8% vs. -4.3%, p = 0.012), with benefits increasing significantly up to week 4.

“Prurigo nodularis is associated with a significantly reduced quality of life and frequent sleep deprivation. This analysis underscores the rapid onset of action of nemolizumab, reducing itching within 48 hours of the first dose, and significantly improving sleep as early as day 4 in moderately to severely affected patients. This symptomatic relief leads to a significant improvement in daily life for these patients. ”

PROFESSOR SONJA STAND Senior Researcher, PROFESSOR OF DERMATOLOGY, UNIVERSITY HOSPITAL MÃœNSTER, MÃœNSTER, GERMANY

Direct anti-inflammatory effects suggested for nemolizumab, leading to early improvement in AD. leads

New and consistent results on nemolizumab in AD were also presented in Abstract # 1200, a post-hoc secondary analysis of Phase 2b data in adult patients with moderate to severe AD, recently published in the Journal of Allergy and Clinical Immunology (JACI) has been published. . From the first week of treatment, nemolizumab showed significant improvement in clinical signs and symptoms of AD as indicated by SCORAD, which by week 16 increased dryness compared to placebo, which could be a result of a beneficial effect of nemolizumab on the skin barrier.

“This analysis is important as it indicates the direct anti-inflammatory effects of nemolizumab and increases our understanding of its mechanism of action, resulting in rapid and profound reduction in itching and skin lesions in patients with atopic dermatitis. ”

PROFESSOR JEAN-DAVID BOUAZIZ LEAD INVESTIGATOR, DERMATOLOGY DEPARTMENT, SAINT LOUIS HOSPITAL, PARIS, FRANCE

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

A third abstract, # 976, looked at pharmacokinetics (PK), safety, and efficacy during nemolizumab treatment for AD in adolescents. AD is problematic in this age group because many everyday activities in a teenage boy, such as exercise and after-school events, lead to increased body temperature and sweating. In addition, as academic and social pressures increase during adolescence, anxiety and stress increase, making symptoms of AD worse. In patients aged 12 to 17 years with moderate to severe pruritus, nemolizumab demonstrated marked improvement in rash, pruritus, sleep and quality of life (QoL) and biomarkers.

About eczema

Atopic dermatitis (AD) is an annoying and debilitating inflammatory skin disease characterized by diffuse skin lesions and constant annoying 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 severe and chronic skin disease can severely impair the patient’s quality of life, lead to sleep disorders and secondary skin infections.4th

About prurigo nodularis

Prurigo nodularis (PN) is a rare, potentially debilitating, chronic skin condition that has thick skin nodules covering large areas of the body and an associated intense, unstoppable itch.5 PN can occur at any age, but is most likely to affect people between the ages of 40 and 69, which can often result in severe impairment of quality of life.4th

The global prevalence of PN is unknown as there are no studies describing the epidemiology of the disease. In the US, the latest estimates suggest that PN will affect 52.9 out of 100,000 people.4th In the European context, rates between 0.65 and 11.1 per 10,000 inhabitants were reported. In addition to the natural variation, this relatively wide range of estimates is partly due to different case definitions and the representativeness of the study populations.6th

About nemolizumab

Nemolizumab is the first monoclonal antibody of its class that is directed against the IL-31 receptor alpha and blocks the signal transmission of the neuroimmune cytokine IL-31.7th IL-31 plays a key role in several disease mechanisms in both atopic dermatitis and prurigo nodularis. With its unique role in directly stimulating sensory neurons associated with itching and contributing to inflammation and barrier disorders, IL-31 is a central mediator that acts as a bridge between the immune and nervous systems while acting directly on structural cells in acts on the skin. Nemolizumab, originally manufactured by Chugai Pharmaceutical Co., Ltd. was licensed to Galderma in 2016 – worldwide except Japan and Taiwan. Nemolizumab is an investigational drug in clinical development for the treatment of atopic dermatitis and prurigo nodularis, the safety and effectiveness of which have not been fully investigated by any regulatory agency. Nemolizumab was granted Breakthrough Therapy status by the US 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 global dermatology company, was founded in 1981 and is now present in over 100 countries with an extensive portfolio of prescription drugs, aesthetic solutions and consumer care products. The company works with health professionals around the world to meet people’s skin health needs throughout their lives. Galderma is a leader in the research and development of scientifically defined and medically proven solutions for the skin. For more information, please visit www.galderma.com

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 ratings. 2018. DOI: 10.1038 / s41572-018-0001-z

3 Silverberg, J, I. Public Health Burdens and Epidemiology of Atopic Dermatitis. 283-289. 2017.

4th Atopic eczema – symptoms. NHS. Available from: https://www.nhs.uk/conditions/atopic-eczema/symptoms/ Access: March 2021

5 Galderma. Data on file.

6th Morgan LI. Christoph. Epidemiology of prurigo nodularis in England. 2021.

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


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