GALDERMA

Galderma today announced the presentation of new phase 2 data supporting the efficacy of its investigational monoclonal antibody, nemolizumab, at the virtual 30^th EADV congress, taking place between 28 September and 2 October 2021.

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

"We are delighted to share new analyses and clinical trial data which reinforce nemolizumab’s therapeutic potential and comprehensive benefits across prurigo nodularis and atopic dermatitis. The scientific evidence for the critical role that the IL-31 pathway plays in the inflammatory process is growing and we are committed to continuing our work diligently to bring nemolizumab to patients living with these debilitating skin conditions.”   BALDO SCASSELLATI SFORZOLINI, M.D., PH.D., GLOBAL HEAD OF R&D, GALDERMA

Nemolizumab significantly reduces itch within 48 hours in PN
Findings from a secondary analysis of a phase 2 trial evaluating the onset of action in pruritus and sleep disturbance in patients with moderate-to-severe PN were the subject of abstract #465. Within 48 hours, nemolizumab significantly reduced severe itch over three times more effectively than placebo (-19.5% vs -5.8%, respectively, p=0.014), a rapid and significant decrease in itch which was maintained for the duration of the study. At Day 4, approximately a quarter of patients were already demonstrating strong reduction in severe itch responses to treatment with nemolizumab, compared to no responses for the placebo group (23.5% vs 0%, p<0.001). At study completion (12 weeks), over 50% of PN patients demonstrated a response to nemolizumab treatment (52.9% vs. 8.3%).

At Day 4, nemolizumab led to a four times greater improvement in sleep disturbance versus placebo (-19.8% vs -4.3%, p=0.012), with benefits significantly increased through week 4.

"Prurigo nodularis is associated with a markedly impaired quality of life and frequent sleep deprivation. This analysis highlights nemolizumab’s rapid onset of action bringing itch reduction within 48 hours of the first dose, and a significant improvement in sleep as early as Day 4 for moderately to severely affected patients. This symptomatic relief translates into a meaningful improvement in day-to-day life for these patients.”   PROFESSOR SONJA STÄNDER LEAD INVESTIGATOR, PROFESSOR FOR DERMATOLOGY, UNIVERSITY HOSPITAL MUENSTER, MUENSTER, GERMANY

Direct anti-inflammatory effect suggested for nemolizumab leading to early improvement in AD
New and consistent findings for nemolizumab in AD were also presented in abstract #1200, a secondary post-hoc analysis of the 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 a significant improvement in the clinical signs and symptoms of AD, as indicated by SCORAD, increasing through week 16. This included early improvement of erythema and excoriation suggests a direct anti-inflammatory effect, whereas improved skin dryness vs placebo could be a consequence of a beneficial effect of nemolizumab on the skin barrier.

"This analysis is important as it points to the direct anti-inflammatory effect of nemolizumab and builds our understanding of its mechanism of action bringing rapid and profound reduction in itch sensations and skin lesions for patients living with atopic dermatitis.”   PROFESSOR JEAN-DAVID BOUAZIZ LEAD INVESTIGATOR, DEPARTMENT OF DERMATOLOGY, SAINT-LOUIS HOSPITAL, PARIS, FRANCE

Marked improvements in signs and symptoms of AD also demonstrated in adolescent patients
A third abstract, #976, considered the pharmacokinetics (PK), safety and efficacy during nemolizumab treatment of AD in adolescents. AD is problematic in this age group as many activities in a teenager’s daily routine, such as sports and extracurricular events result in increased body temperature and sweating. Furthermore, as academic and social pressures increase during adolescence, anxieties and stress levels rise, worsening symptoms of AD. In patients aged 12-17 with moderate-to-severe pruritus, nemolizumab demonstrated a marked improvement in rash, itch, sleep and 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 itch.^1,2 Reported prevalence of AD varies greatly, ranging from 1% to 25% of the population depending on the geography and age range.³ This severe and chronic skin disease can have a profound impact on patients’ quality of life, leading to sleep difficulties and causing secondary skin infections.⁴

About prurigo nodularis
Prurigo nodularis (PN) is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated intense unrelenting itch.⁵ While PN can occur at any age, it is most likely to affect people between the ages of 40 and 69, frequently leading to severe impairment in quality of life.⁴
The global prevalence of PN is unknown as there are no studies describing the epidemiology of the condition. In the U.S., the latest estimate is that PN affects 52.9 people in every 100,000.⁴ In the European context, rates of between 0.65 and 11.1 per 10,000 population have been reported. In addition to natural variation, this relatively wide range of estimates is partly due to differences in case definition and the representativeness of the study populations.⁶

About nemolizumab
Nemolizumab is a first-in-class monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from neuroimmune cytokine IL-31.⁷ IL-31 plays a key role in multiple disease mechanisms in both atopic dermatitis and prurigo nodularis. With its unique role in directly stimulating sensory neurons related to itch and contributing to inflammation and barrier dysfunction, IL-31 is a central mediator that serves as the bridge between the immune and nervous systems while directly acting on structural cells in the skin. Nemolizumab, initially developed by Chugai Pharmaceutical Co., Ltd., was subsequently licensed to Galderma in 2016 – worldwide except Japan and Taiwan. Nemolizumab is an investigational agent under 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 U.S. 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 created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in 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 dermatis. Nature Reviews. 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 from: https://www.nhs.uk/conditions/atopic-eczema/symptoms/ Accessed: March 2021
⁵ Galderma. Data on File.
⁶ Morgan LI. Christopher. 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 Dermatolog Treat. 2017;28(7):591-599. DOI: 10.1080/09546634.2017.1290205

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