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).2 Published 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.
DR JONATHAN SILVERBERG
|
|
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210408005341/en/
Contact information
Investor and Media Relations
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50
Media Contact
Lauren Starr
Head of Franchise Communications
media@gladerma.com
+41 79 771 52 45
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
EIG Acquires a 49.87% Stake in Transportadora de Gas del Perú (TgP)19.12.2025 19:42:00 EET | Press release
EIG, through its managed investment vehicles, acquired a 49.87% equity stake in Transportadora de Gas del Perú S.A. (“TgP”) from Canada Pension Plan Investment Board today. TgP operates Peru’s principal natural gas and natural gas liquids pipelines under a long-term concession, supplying approximately 40% of the country’s power generation. “We are delighted to complete this transaction and embark on the next chapter of our partnership with TgP,” said Matt Hartman, EIG’s Global Head of Infrastructure. “Our priority is to support TgP’s operational excellence and long-term stability, delivering value for customers and stakeholders throughout Peru.” About EIG EIG is a leading institutional investor in the global energy and infrastructure sectors with $24.3 billion assets under management as of September 30, 2025. EIG specializes in private investments in energy and energy-related infrastructure on a global basis. During its 43-year history, EIG has committed over $51.7 billion to the energ
CyberArk Named a Leader in IDC MarketScape: Worldwide Integrated Solutions for Identity Security 202519.12.2025 18:00:00 EET | Press release
CyberArk (NASDAQ: CYBR), the global leader in identity security, today announced that it has been recognized as a Leader in the IDC MarketScape: Worldwide Integrated Solutions for Identity Security 2025 Vendor Assessment. CyberArk extends dynamic privilege controls across all identity types with its unified platform, enabling organizations to improve efficiencies and streamline security operations. This IDC MarketScape report notes, “More change has occurred in the identity security marketplace in the past two years than in almost a decade. Vendors are entering a new phase defined by the emergence of intelligence technologies, none of which are specifically defined by any industry standards. Though different by design, the new adjacent IAM offerings are largely focused on improved vulnerability and threat management visibility and automated and predictive attack detection capabilities.” It also notes, “By addressing these evolving identity types within a unified framework, CyberArk enh
New York Liberty and Ant International’s Alipay+ Announce Multiyear Partnership Focused on Empowerment, Sustainability and Youth Development19.12.2025 15:30:00 EET | Press release
The New York Liberty and Ant International’s Alipay+, a leading cross-border fintech services platform based in Singapore, today announced a multiyear partnership, making Alipay+ an Official Sponsor and Innovation Partner for Sustainability of the New York Liberty. Through this partnership, Alipay+ and the Liberty will jointly support community programs designed to advance community empowerment, environmental sustainability and youth development across New York City. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251219678825/en/ Peng Yang, CEO, Ant International and Clara Wu Tsai, Vice Chair, Brooklyn Sports and Entertainment; Governor, New York Liberty “Our partnership with Alipay+ goes beyond the game,” said Keia Clarke, Chief Executive Officer, New York Liberty. “Together, we are investing in the future of New York—its people, its environment, and its youth. Ant International’s commitment to community empowerment, sustai
Parse Biosciences and Codebreaker Labs Partner to Apply Whole Transcriptome Single Cell Profiling and Causal Genomics at Scale19.12.2025 15:00:00 EET | Press release
Parse Biosciences, the leading provider of scalable and accessible single cell sequencing solutions, today announced a collaboration with Codebreaker Labs to develop and validate a breakthrough platform capable of testing thousands of genetic variants in parallel and measuring their effects at single cell resolution. By combining Codebreaker’s synthetic biology platform and variant engineering capabilities with the scale and accessibility of Parse’s Evercode™ technology, the collaboration aims to generate the causal data increasingly sought by AI developers, drug discovery teams, and clinical researchers. Today’s genomic studies rely heavily on observational data, or variants that appear in large populations. But rare and private variants, often only seen in one individual or family, are nearly impossible to study this way because too few carriers of the variant exist to draw statistically meaningful conclusions. As a result, even the most advanced models trained on observational datas
Cyviz Awarded Two Classified NATO Defense Contracts19.12.2025 09:00:00 EET | Press release
Norwegian technology and platform company Cyviz AS has been awarded two classified defense contracts by major European NATO-partner nations to deliver a fully mobile, containerised Command & Control (C2) capability, strengthening Europe’s operational readiness in high-threat and expeditionary environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251218625485/en/ Image from a previous military exercise where Cyviz demonstrated a mobile command center solution. The contracts cover the design, integration, and delivery of secure, deployable operations centres engineered to NATO security standards, enabling military and security forces to establish full theatre-class command capability wherever operations require. Due to the sensitive nature of the missions, contract value and customer identities remain undisclosed. From Demonstrated Readiness to Operational Deployment The awards follow growing interest among European def
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom