GALDERMA
20.2.2020 09:02:05 CET | Business Wire | Press release
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
NetApp Helps Customers Accelerate Adoption of Latest VMware Cloud Foundation Innovations2.9.2026 22:30:00 CEST | Press release
NetApp solutions validated to support VCF 9.1, giving mutual customers access to a modern private cloud with enterprise-grade data management, cyber resilience, and cost-efficient scaling NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, announced new capabilities in NetApp ONTAP® have been tested and validated to support VMware Cloud Foundation (VCF) 9.1, giving customers an optimized and secure data infrastructure foundation for their private and hybrid clouds. By combining the advanced capabilities of VCF 9.1 with cost-effective and enterprise data management with built-in security features from NetApp, including safeguarding data against ransomware attacks with rapid recovery, mutual customers can lower costs and accelerate the deployment of their AI software into production. VMware Cloud Foundation 9.1 provides enterprises with a unified private cloud platform for running both traditional and modern workloads. NetApp's solutions are tested and validated to suppo
Venture Global Announces Closing of $3,000,000,000 364-Day Senior Secured Revolving Credit Facility2.9.2026 22:30:00 CEST | Press release
Venture Global, Inc. (“Venture Global”) announced today that its subsidiary Venture Global LNG, Inc. (“VGLNG”) has entered into a new, $3,000,000,000 364-day revolving credit facility (the “Facility”). Venture Global expects to use the proceeds from borrowings under the Facility for general corporate purposes of VGLNG and its subsidiaries, including to fund certain project costs for the CP2 and Plaquemines bolt-on expansions prior to their respective FIDs. Bank of America, N.A. served as Coordinating Lead Arranger and Sole Bookrunner and will also serve as Administrative Agent. BBVA, Goldman Sachs, ING, J.P. Morgan, Mizuho, MUFG, NBC, RBC, Scotia, SMBC, U.S. Bank, and Wells Fargo served as Coordinating Lead Arrangers and Barclays, Santander, and Deutsche Bank served as Joint Lead Arrangers. About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (LNG) with over 100 MTPA of capacity in production, construction, or development. Vent
Invivoscribe Begins Commercial Shipments of PrepQuant™ Systems, Enabling High-Sensitivity Sample Preparation for MRD Testing2.9.2026 21:31:00 CEST | Press release
New automated platform is designed to improve the quality, efficiency, and consistency of DNA extraction and concentration from large-volume blood and plasma samples, supporting downstream assays capable of detecting disease-associated signals at MRD sensitivity levels. Invivoscribe®, a global leader in precision diagnostics and measurable residual disease (MRD) testing, today announced that commercial shipments of the PrepQuant™ System have begun in North America. First unveiled at the American Association for Cancer Research Annual Meeting in April 2026, PrepQuant is now being delivered to customers, marking the platform's progression from development and validation into commercial deployment. The commercial milestone extends Invivoscribe's capabilities into laboratory instrumentation and addresses a critical bottleneck in highly sensitive molecular testing: efficiently recovering, concentrating, and quantifying DNA from larger blood and plasma inputs. PrepQuant is assay agnostic, de
C.H. Guenther Opens Centre of Excellence in Coventry, UK to Accelerate Bakery Innovation and Support Future Manufacturing Growth Across UK and Europe2.9.2026 18:00:00 CEST | Press release
C.H. Guenther & Son LLC (“C.H. Guenther” or “CHG”), a leading food manufacturer, has opened a new Centre of Excellence (the “Centre”) at its flagship Coventry bakery, creating a dedicated innovation and customer collaboration hub designed to accelerate the development of premium bakery products across the UK and Europe. The new facility has been designed to support CHG’s customers including leading global quick service restaurants, foodservice operators and retailers as they develop, test and refine new bakery products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902696890/en/ The purpose-built, 172-square-metre Centre of Excellence brings together a commercial-scale bakery, customer demonstration kitchen, sensory evaluation facilities, innovation suite and dedicated collaboration spaces in one specialized location. Designed to support and accelerate product development from concept through to commercial manufacturing,
Record Asset Management Enters New Phase of Growth2.9.2026 17:35:00 CEST | Press release
Record Asset Management GmbH (“RAM”), a subsidiary of London-listed Record plc (“Record” or the “Group”), is pleased to announce that it is now operating cashflow positive, thereby marking a transition from its investment phase into a growth business within the Group, and a significant milestone towards sustainable profitability. RAM is the European asset management arm of Record, the London-listed specialist investment group managing USD 122 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom the Group has built long-standing relationships through its focus on bespoke investment and risk management solutions. RAM was established as a sister company to Record’s core currency business and obtained its BaFin license in 2022. RAM has grown rapidly in the last two years and has developed into a diversified private markets platform with dedicated infrastructure e
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