GALDERMA
6.12.2021 10:02:06 CET | Business Wire | Press release
Galderma today announced that the Journal of Allergy and Clinical Immunology has published gene expression data that demonstrate the positive anti-inflammatory effect and mode of action of nemolizumab in patients with moderate to severe Prurigo Nodularis (PN), confirming the potential of nemolizumab as a major player in the treatment of PN, effectively reducing both pruritus and severity of skin lesions in PN patients.
“Transcriptome data is an important step in validating the therapeutic effect of nemolizumab through a deeper understanding of the mode of action at a cellular level. With these data, we are advancing dermatology and contributing to improving our understanding of PN. These data emphasize that nemolizumab may have a key role to play for patients with moderate to severe PN. This will be confirmed by our ongoing nemolizumab Phase 3 studies in PN.”
Dr. Baldo Scassellati Sforzolini
|
PN is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus. It frequently leads to a severe quality of life impairment. Despite the significant unmet medical needs, there are currently no registered therapeutic options.
The data published today provide the first comprehensive view of the gene expression and transcriptomic changes in PN skin, and characterize the mechanism of action of nemolizumab, supporting previous published data.
The results demonstrate that nemolizumab effectively decreases IL-31 responses in PN skin, leading to effective suppression of downstream inflammatory responses including Th2/IL-13 and Th17/IL-17 responses. This is accompanied by decreased keratinocyte proliferation and normalization of epidermal differentiation and function. The results showed improvement in lesions and pruritus, and stabilization of extracellular matrix remodeling and processes associated with cutaneous nerve function.
“The Journal of Allergy and Clinical Immunology publication demonstrates the broad response to IL-31 receptor inhibition with nemolizumab and confirms the critical upstream role of IL-31 in PN pathogenesis, further supporting the potential benefits of nemolizumab for patients living with this severe, chronic disease.”
Pr. Johann E. Gudjonsson
|
The full publication is available at www.jacionline.org .
About transcriptomic data
Transcriptomics studies the set of RNA transcripts produced by the genome using high-throughput sequencing and bioinformatics. It can help researchers to gain a deeper understanding of what constitutes a specific cell type, how that type of cell normally functions, and how changes in the normal level of gene activity may reflect or contribute to disease. In clinical drug discovery it provides insight into the mechanism of action of the drug and can help identify possible side effects early in the discovery process.
About nemolizumab
Nemolizumab is a first-in-class humanized monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31.i
IL-31 plays a key role in multiple disease mechanisms in both atopic dermatitis and PN, 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 is the world’s largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we’re in shapes our life stories, we are advancing dermatology for every skin story. For more information: www.galderma.com
i Saleem M. et al. Interleukin-31 pathway and its role in atopic dermatitis: a systematic review. J Dermatology Treat. 2017;28(7):591-599. DOI: 10.1080/09546634.2017.1290205
View source version on businesswire.com: https://www.businesswire.com/news/home/20211206005318/en/
Link:
About Business Wire
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
Veristat Strengthens Biostatistics, Drug Development Advisory, and People Leadership to Support Growth in Complex Clinical Development23.6.2026 13:05:00 CEST | Press release
Dr. Zhaohui Su and Dr. Gil Fine deepen Veristat’s biostatistics expertise, Scott Tarrant leads Strategic Drug Development Advisory, and Clint Wolfe joins as Chief Human Resources Officer VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, today announced four strategic leadership hires that advance its mission to accelerate novel therapy approvals in complex disease areas, including cell and gene therapy, oncology, and rare disease. Building on its 30-year foundation in biostatistics and its recent acquisition of the medical writing and regulatory submission business of Certara, Veristat is deepening its scientific expertise and expanding its operational leadership to meet growing client demand. Dr. Zhaohui Su and Dr. Gil Fine join Veristat’s Strategic Drug Development Advisory team in biostatistical leadership roles, collaborating with Scott Tarrant, who has been named Executive Vice President of the team. In addition, Clint Wolfe
Bacardi Takes Full Ownership of TEELING® Irish Whiskey23.6.2026 13:00:00 CEST | Press release
Irish whiskey brand joins family-owned company’s portfolio of premium brands Bacardi Limited has announced the completion of a transaction that makes the family-owned company the sole owner of the Teeling Whiskey Company and the TEELING® Irish whiskey brand. Founders Jack and Stephen Teeling will remain a part of the brand, shaping its future and driving growth for the long term as strategic advisors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623858211/en/ Three expressions of Teeling Irish Whiskey: Single Grain, Small Batch and Single Malt Today’s announcement follows the successful relationship the two companies have enjoyed since Bacardi acquired a minority stake in the Dublin-based whiskey company in 2017. Bacardi subsequently increased its stake to become the majority shareholder in 2022. “TEELING is the perfect fit for Bacardi,” says Mahesh Madhavan, Chief Executive Officer, Bacardi Limited. “The brand stands f
Bending Spoons S.p.A. announces launch of initial public offering23.6.2026 12:15:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the launch of its initial public offering (the “IPO”) of its ordinary shares. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 are being offered by Bending Spoons and 23,572,375 are being offered by certain selling shareholders (the “Selling Shareholders”). In connection with the offering, Bending Spoons and the Selling Shareholders have granted the underwriters a 30-day option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and an additional 3,451,626 ordinary shares from the Selling Shareholders at the IPO price, less underwriting discounts and commissions. The IPO price is currently estimated to be between $26.00 and $28.00 per share. Bending Spoons has applied to list its ordinary shares on the Nasdaq Global Select Market under the ticker symbol “BSP.” Goldman Sachs International, J.P. Morgan, and Allen & Company LLC are acting as joint l
WSJ Intelligence Study: Uniquely Human Skills Deemed "Non-Replicable" in Automated Future23.6.2026 12:00:00 CEST | Press release
Philip Morris International and WSJ Intelligence reveal a "Human Premium" in the AI era, warning of cognitive atrophy risks alongside rapid corporate automation Philip Morris International (PMI) (NYSE: PM) and WSJ Intelligence, the in-house thought leadership consultancy for The Wall Street Journal's commercial sales organization, today revealed topline findings from a forthcoming study at Journal House during the Cannes Lions International Festival of Creativity. The study delivered a clear takeaway for global businesses: human cognition must be the absolute forefront of the modern corporate landscape. The findings show that uniquely human skills are vital, non-replicable, and increasingly valuable in an AI-embedded future, with creative empathy and critical thinking among the most distinctive workplace advantages. Surveying over 2,500 business professionals across the United States, United Kingdom, Italy, South Africa and Brazil, the joint initiative is the largest-scale research pro
Bitcoin Suisse Receives MiCAR License and Launches European Expansion23.6.2026 11:37:00 CEST | Press release
The Liechtenstein Financial Market Authority has granted Bitcoin Suisse (Europe) AG a license as a Crypto Asset Service Provider (CASP) under MiCAR. The European entity of Bitcoin Suisse can now serve clients across selected EEA markets, with Roman Przibylla appointed CEO to lead the expansion. After more than a decade as Switzerland's crypto pioneer, the Bitcoin Suisse Group ("Bitcoin Suisse") is expanding across Europe. Its European entity, Bitcoin Suisse (Europe) AG, founded in 2018, has been granted a license as a Crypto Asset Service Provider (CASP) under MiCAR by the Liechtenstein Financial Market Authority (FMA), building on its long-standing registration under the Token and TT Service Provider Act (TVTG). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622188006/en/ left: Andrej Majcen, Co-Founder and Group CEO of the Bitcoin Suisse Group; right: Roman Przibylla, CEO of Bitcoin Suisse (Europe) AG Across Europe, Bit
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