Galderma Announces Publication of Phase 2b Trial Results Demonstrating the Rapid and Long-lasting Benefits of Nemolizumab in Clinical Trial Subjects With Uncontrolled Atopic Dermatitis

Galderma today announced that the Journal of the European Academy of Dermatology and Venereology (JEADV) has published full results from a post-hoc analysis of the phase 2b study of its investigational therapy, nemolizumab, in adult patients with moderate-to-severe atopic dermatitis (MtS AD).²Published online on March 12, results of the analyses show that nemolizumab led to rapid and sustained improvements in itch, sleep, and skin lesions in adult patients with uncontrolled MtS AD.²

The published analysis evaluated the efficacy of nemolizumab versus placebo in adult patients with MtS AD:²

• Nemolizumab-treated patients experienced significant itch relief within 48 hours of treatment (-22.8% vs -12.3%; p=0.005). This improvement was sustained over the trial, achieving even greater treatment benefit at week 16 (-68.5% vs -30.9%; p<0.001 at week 16).
• Rapid improvement of sleep disturbance for patients treated with nemolizumab (30mg) from day three of treatment (-26.6% vs -9.0%; p<0.001) with further improvement by week 16 of treatment (-76.0% vs -36.5%; p<0.001).
• Clinically meaningful reductions of 75% EASI were observed at week 16 in 50.0% of nemolizumab patients versus 15.9% of placebo patients (p<0.001) and 90% reductions of EASI were observed for 36.0% of nemolizumab patients and 6.8% of placebo patients (p<0.001).
• Nemolizumab was safe and well-tolerated in this population, with nasopharyngitis and upper respiratory tract infection being the most common adverse events observed.

“This post-hoc analysis published today in the Journal of the European Academy of Dermatology and Venerology further emphasizes the significant potential of nemolizumab in treating moderate-to-severe atopic dermatitis,” said Dr Baldo Scassellati Sforzolini, Global Head of R&D at Galderma. “In our continued commitment to advancing dermatology, these findings demonstrate the multitude of potential benefits that nemolizumab could bring to people living with this severe and chronic disease.”

"Atopic dermatitis is a chronic and debilitating disease. We particularly need more treatment options for patients with moderate-to-severe atopic dermatitis. Results from these analyses build on our previous knowledge of nemolizumab’s efficacy in atopic dermatitis and show the potential benefits that it offers for patients with moderate-to-severe atopic dermatitis.” DR JONATHAN SILVERBERG LEAD AUTHOR, DIRECTOR OF CLINICAL RESEARCH, GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES

Analysis methodology
The published post-hoc analysis evaluated the efficacy of nemolizumab versus placebo in adult patients with MtS AD with baseline EASI scores ≥16 (nemolizumab: n=50, placebo: n=44) at week 16. A prior study of nemolizumab has defined MtS AD using an inclusion criteria of EASI ≥12.

About atopic dermatitis
Atopic dermatitis is a disruptive and debilitating inflammatory skin disease, characterized by skin lesions and intense itching, which impacts an estimated 1-3% of adults worldwide.^3,4 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.⁵

About nemolizumab
Nemolizumab is a first-in-class humanized monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31.⁶ IL-31 plays a key role in multiple disease mechanisms in both atopic dermatitis and prurigo nodularis, a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus (itching). With its unique role in directly stimulating sensory neurons related to itch and contributing to inflammation and barrier dysfunction, IL-31 is 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

¹ Atopic Dermatitis. National Eczema Association. Available from: https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/ Accessed: March 2021.
² Silverberg JI. et al. Nemolizumab is associated with a rapid improvement in atopic dermatitis signs and symptoms: subpopulation (EASI ≥ 16) analysis of randomized phase 2B study. JEADV. 2021. DOI: 10.1111/jdv.17218
³ Langan S. et al. Atopic dermatitis. The Lancet. 2020;396(10247):345-360. DOI: https://doi.org/10.1016/S0140-6736(20)31286-1
⁴ Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl1):8-16. DOI: https://doi.org/10.1159/000370220
⁵ Atopic Eczema – Symptoms. NHS. Available from: https://www.nhs.uk/conditions/atopic-eczema/symptoms/ Accessed: March 2021.
⁶ 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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