GALDERMA
Galderma today announced that The New England Journal of Medicine (NEJM) has published full results from the Phase 2 study of its investigational therapy nemolizumab in adult patients suffering from moderate-to-severe prurigo nodularis (PN).
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. Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31 that play a key role in the pathogenesis of PN. Nemolizumab’s safety and efficacy have not been fully evaluated by any regulatory authority.
In this study, 70 patients with moderate to severe PN and severe pruritus were randomized to receive subcutaneous nemolizumab 0.5 mg/kg every 4 Weeks from baseline to Week 8 or matching placebo injections (at weeks 0,4 and 8). Nemolizumab met the primary endpoint of a greater improvement in Peak Pruritus Numerical rating scale (PP-NRS) from baseline to Week 4 compared to placebo. The baseline PP-NRS was 8.4 in both groups. At week 4, in nemolizumab arm PP-NRS was reduced from baseline by 4.5 (53.0%) compared to 1.7 (20.2%) in placebo; P<0.001. All the other measures showed a significant difference in patients taking nemolizumab. At week 18 (10 weeks after the last dose), 38 percent of the patients who received nemolizumab were clear or almost clear of PN compared to 6 percent of the patients who received placebo; P=0.001. Nemolizumab was well tolerated and no imbalance in adverse events was observed between the two groups. The full publication is available at https://www.nejm.org/doi/full/10.1056/NEJMoa1908316
“Prurigo nodularis is known to have a profoundly negative impact on quality of life of patients, and despite significant unmet needs, there are currently no registered therapeutic options” said Dr Thibaud Portal, Global Head of Prescription medicines at Galderma. “The Phase 2 study results indicate that nemolizumab may have a key role to play for patients with moderate to severe prurigo nodularis. We are fully committed to test this drug further in Phase 3 studies and determined to bring solutions for patients suffering from prurigo nodularis.”
“The New England Journal of Medicine publication brings important attention to prurigo nodularis, where it has been very challenging for clinicians to take care of their patients in the absence of any registered therapy targeting prurigo nodularis” said Sonja Ständer, M.D., Center for Chronic Pruritus, Department of Dermatology, University of Münster, Germany and lead author of the NEJM paper. “We are encouraged by the consistent findings across this study and look forward to further clinical investigation with nemolizumab.”
In November 2019, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to the investigational therapy nemolizumab for the treatment of pruritus associated with PN. Galderma is actively preparing for the initiation of a Phase 3 pivotal program with nemolizumab in adult patients with PN in 2020.
About Nemolizumab
Nemolizumab, a first-in-class humanized monoclonal antibody, is directed against the IL-31 receptor alpha, which blocks signaling from IL-31. 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 and its safety and efficacy have not been fully evaluated by any regulatory authority.
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20200220005309/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
Suzano Reports Increased Operational Efficiency With Lower Cash Cost in the Third Quarter of 20256.11.2025 23:58:00 CET | Press release
Ongoing improvement in cost competitiveness: cash production costs continue to reduce (down 7% Y-o-Y), due to the increased contribution from the Ribas do Rio Pardo unit. Continued progress in integrating recent acquisitions: Suzano Packaging reported its first positive Adjusted EBITDA from the US operations acquired one year ago. Suzano, the world’s largest pulp producer, announces its results for the third quarter of 2025 (3Q25), reporting sales of 3.6 million tonnes of pulp and paper combined, a 20% increase on the same quarter last year (3Q24). The positive result is driven by the operations of the Ribas do Rio Pardo pulp mill, inaugurated in 2024, and by the integration of paper production from assets acquired in the United States in October 2024. The cash cost of pulp production (excluding downtime) was R$801 per tonne, a 7% reduction compared to 3Q24, another positive highlight of the quarter. The results reflect the continuation of the downward trend in production costs and the
Vedanta Resources Launches CopperTech Metals to Bolster U.S. Copper Security and Advance Technology and Infrastructure Transformation6.11.2025 17:45:00 CET | Press release
CopperTech Metals Combines World-Class Konkola Mines' Copper and Cobalt Producing Heritage with Cutting-Edge Mining Technology and Artificial Intelligence to Advance U.S. Critical Mineral Independence and Serve America's Growing Infrastructure Needs$1.5 Billion Investment Program to Leverage Advanced Mining and Cutting-Edge AI-Driven Resource Identification and Extraction Technology to Propel Konkola's Operations into One of the Largest in the World Vedanta Resources Limited ("Vedanta") today announced the launch of CopperTech Metals Inc. ("CopperTech" or the "Company"), a U.S.-domiciled company with a mission to 'Power the Copper Century' and to bolster America's copper security needs while capitalizing on surging copper demand driven by artificial intelligence, data center expansion, grid modernization, defense technologies and industrial onshoring requirements. CopperTech will1 own and operate the Konkola Copper Mines in Zambia, one of the highest-grade copper producing assets in th
NJ Bio Bridges the Translation Research Gap with the Asset Purchase and Integration of L2P®Services6.11.2025 17:11:00 CET | Press release
NJ Bio, Inc., a premier contract research and clinical manufacturing service provider in Princeton, New Jersey has announced the asset purchase and full integration of the research services of L2P Research Labs® (“Lab to Pharmacy”), further expanding its service portfolio, and bridging the translational research gap. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251106703527/en/ NJ Bio, Inc. now offers translational research services after completing asset purchase and full integration of the services of L2P® Research Labs, enhancing the discovery-to-development pipeline Currently, the attrition rate of biological molecules moving past phase 1 clinical trials is very high and the way to overcome this challenge is through translational research. NJ Bio specializes in preclinical and early-phase clinical research and development, with a primary focus on ADCs, bioconjugation, custom synthesis, oligonucleotides, and mRNAs. Howe
DevvStream Reports Fiscal Year 2025 Results and Advances Digital-Asset and Tokenization Strategy6.11.2025 17:01:00 CET | Press release
Company strengthens balance sheet, launches disciplined digital-asset treasury, and sets stage for acquisition-led growth in sustainability markets DevvStream Corp. (Nasdaq: DEVS) (“DevvStream” or the “Company”), a leading carbon management and environmental-asset monetization firm, today announced financial results for its fiscal year ended July 31, 2025, and provided an update on strategic initiatives designed to enhance liquidity, expand technology capabilities, and position the Company for scalable, acquisition-driven growth. Fiscal 2025 Highlights Completed Nasdaq listing and de-SPAC transaction, establishing DevvStream as one of the few publicly traded pure plays in carbon and renewable-energy asset monetization. Closed initial $10 million tranche under the Helena $300 million convertible-note facility, providing liquidity to launch the Company’s digital-asset treasury. Reported initial revenue as the Company begins monetizing its environmental-asset pipeline. Successfully comple
BST Global Launches 2026 AI + Data Impact Survey for the AEC Industry6.11.2025 16:41:00 CET | Press release
BST Global, the leading provider of AI-powered project intelligence™ solutions for the AEC industry, has launched its second annual global AI + Data Survey. Seeking insights from technology and data leaders of architecture, engineering and environmental consultancies around the world, the survey will be available until 11:59 p.m. ET, December 31, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105615222/en/ BST Global, the leading provider of AI-powered project intelligence™ solutions for the AEC industry, has launched its second annual global AI + Data Survey. Seeking insights from technology and data leaders of architecture, engineering and environmental consultancies around the world, the survey will be available until 11:59 p.m. ET, December 31, 2025. Conducted in partnership with BST Global’s AI + Data Consortium and the American Council of Engineering Companies' (ACEC) Technology Committee, the survey focuses s
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