Business Wire

Galderma Announces New Data Demonstrating the Positive Anti-inflammatory Effect and Mode of Action of Nemolizumab in Patients With Moderate to Severe Prurigo Nodularis

Share

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
Global Head of R&D, GALDERMA
 

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
M.D., Department of Dermatology, University of Michigan, Ann Arbor, MI, U.S.
and lead author of the JACI paper

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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Contact

Galderma
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50

Rachel Mooney
Global Franchise Communications
rachel.mooney@galderma.com
+41 76 261 64 41

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

Kyowa Kirin Receives European Commission Approval for Use of CRYSVITA®▼(burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)19.8.2022 11:30:00 EEST | Press release

Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin) today announced that the European Commission (EC) approved CRYSVITA® (burosumab) for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.1 CRYSVITA is also already licensed in the EU for use in the rare disease X-Linked Hypophosphataemia (XLH), for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults.2 Also known as oncogenic osteomalacia, TIO is an acquired disorder caused by typically small, slow-growing, benign PMTs.3,4 It is a rare condition with fewer than 1000 cases reported in the medical literature,4 which mainly affects adults and with a mean onset age of 40 – 45 years.3,5 TIO is associated with progressive and debilitating musculoskeletal deficits,6,7 ultimately having a detr

Kapruvia® approved in Switzerland with additional regulatory decisions expected in H2 202219.8.2022 08:00:00 EEST | Press release

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that they have received approval for Kapruvia® from the Swiss Agency for Therapeutic Products (Swissmedic). Kapruvia® will be the first therapy available for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients. Swissmedic approval for Kapruvia® follows approvals by the U.S. Food and Drug Administration, by the European Medicines Agency, by the UK Medicines and Healthcare products Regulatory Agency, as well as by Health Canada. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220818005552/en/ “The approval of Kapruvia® in Switzerland is the next step on our journey to bring this breakthrough treatment to hemodialysis patients living with CKD-associated pruritus around the world,” said Dr. Klaus Henning Jensen, Chief Medical Officer of CSL Vifor. “There is a

Dermaliq Therapeutics announces first patient dosed in Phase 1b/2 trial evaluating DLQ02 for treatment of plaque psoriasis18.8.2022 19:27:00 EEST | Press release

Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first patient dosed in a Phase 1b/2a trial with DLQ02, a topical calcineurin inhibitor. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ02 in patients with plaque psoriasis. “DLQ02 evaluates for the first time hyliQTM, a novel platform technology in dermatology to create best in-class topical therapies with superior bioavailability,” said Betsy Hughes-Formella, PhD, Chief Scientific Officer at Dermaliq. “Calcineurin inhibitors for the treatment of psoriasis are a standard of care when given orally, albeit being associated with significant risk for systemic side effects. DLQ02 is designed to overcome the challenges of topical delivery of this drug class with reduced risk profiles. We are convinced DLQ02 has the potential to transform topical psoriasis therapy for millions of patients.” The r

Aero Secures $65M in Series B Financing to Accelerate the Future of Premium Air Travel18.8.2022 19:00:00 EEST | Press release

Aero Technologies, Inc. the next-generation premium air travel company, which serves routes in both the US and Europe, today announced a $65M capital raise, $50M in Series B funding and $15M in convertible notes, for a total post-money valuation of $300M. The funding round was co-led by AlbaCore Capital Group, one of Europe’s leading alternative investment firms, and returning investors Expa and Keyframe Capital, with new investment from Capital One Ventures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220818005095/en/ (Photo: Business Wire) Inspired by the golden age of aviation and designed for modern life, Aero is redefining semi-private air travel. Aero serves premium leisure travelers through private terminals, enriching the experience with personalized Concierge services - from booking to touchdown. With its fleet of sleek, black planes, Aero offers elevated, effortless guest experiences to curated destinations with

Methane Electrolysis Can Decarbonize LNG/LPG Imports and Achieve EU’s Climate Targets18.8.2022 15:00:00 EEST | Press release

To become independent of Russian natural gas imports by 2027, the European Union is increasing near-term imports of US or Azerbaijan liquefied natural gas (LNG) or liquefied petroleum gas (LPG). The main element of LNG, methane, is the second leading greenhouse gas contributing to climate change. Environmental organizations warn that long-term supply contracts for the fossil LNG will undermine the European Green Deal. The German company Graforce has developed a methane electrolysis technology (plasmalysis) that uses LNG or LPG to produce hydrogen and solid carbon for dioxide-free energy generation. Compared to water electrolysis, plasmalysis requires only one fifth the energy to produce the same amount of hydrogen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220818005013/en/ Graforce has developed methane electrolysis plants. Errected at LNG terminals or other decentralized locations, they can decarbonize energy supply, a

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