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
RSA Announces Expanded Partnership with Microsoft, Enhances Leadership in Passwordless Identity Security24.3.2026 17:00:00 CET | Press release
Innovative partnership ushers in new era of secure, AI-powered workforce authentication RSA today announced expanded support for the new Microsoft 365 E7: The Frontier Suite solution at RSAC Conference 2026. This new support joins additional passwordless capabilities that provide organizations with enhanced security, seamless experience, and resilient operations as they embrace the future of AI-driven productivity. By integrating RSA® ID Plus for Microsoft with Microsoft 365 E7, enterprises can ensure trusted authentication for both human users and AI agents, while safeguarding sensitive data and privileged operations across hybrid, cloud, and on-premises environments. This deployment follows RSA joining the Microsoft Intelligent Security Association (MISA), launching RSA Advisor for Admin Threats in Microsoft Security Copilot, and deploying RSA ID Plus Admin Logs Connector, further strengthening the ongoing collaboration between RSA and Microsoft. “The rise of AI agents in the enterpr
Lexon × Jeff Koons Unveil the Chromatic Collection: a Colorful New Chapter for the Acclaimed Balloon Dog Lamp and Balloon Dog Speaker24.3.2026 15:10:00 CET | Press release
Eight new models introduce vibrant color variations, expanding the collection’s appeal to new and existing collectors alike. Following the success of its 2025 inaugural edition, the Lexon × Jeff Koons collaboration enters a bold new era with the launch of the Chromatic Collection—a colorful evolution of its Balloon Dog Lamp and Balloon Dog Speaker. Pre-orders will be available starting March 24, 2026, exclusively on lexon-design.com as part of a time-limited edition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324498068/en/ Lexon x Jeff Koons — new Chromatic Collection Retaining the signature translucent body that reveals the technology within, the Chromatic Collection introduces eight models: Balloon Dog Lamps in Gold, Blue, Red, and Platinum, and Balloon Dog Speakers in Gold, Blue, Red, and White, reinforcing the collectible nature of the series, offering new audiences an entry point while giving existing collectors
iQmetrix Joins TM Forum as ODA Component Directory Partner, Giving Telecom Operators a Faster, Cleaner Path to Modern Commerce24.3.2026 15:00:00 CET | Press release
Platform’s Standards-Based Architecture Reduces Integration Risk and Accelerates Transformation for CSPs Worldwide iQmetrix, the global provider of Interconnected Commerce solutions purpose-built for telecom retail, today announced it has joined TM Forum and earned recognition as an Open Digital Architecture (ODA) Component Directory Partner. The achievement validates that iQmetrix aligns with the ODA vision and that its platform is built around standardized open APIs, modular cloud-native components, and interoperable architecture aligned with how leading operators are building their digital futures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324562860/en/ iQmetrix partners with TM Forum’s ODA Component Directory to accelerate open, future‑ready telecom transformation The recognition comes as communications service providers (CSPs) accelerate AI adoption and move away from integration-heavy legacy environments. For o
Miro Acquires Reforge to Help Organizations Navigate the Transition to AI24.3.2026 14:00:00 CET | Press release
Together, Reforge and Miro will provide a powerful and highly differentiated solution for teams that blends the tools and knowledge needed to innovate in the AI era Miro®, the AI Innovation Workspace for teams, today announced that it has acquired (subject to customary closing conditions) Reforge, an AI platform for product teams. The deal includes Reforge's team, learning platform, and AI-powered product development tools. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324623461/en/ Organizations are grappling with how to leverage AI to its full potential. In many cases, the problem is not how to code faster, but deciding what to build. That's the bottleneck slowing companies down today. Miro and Reforge are both solving this challenge for customers – tackling the need to build both at speed and with clear strategic direction. Miro brings a collaborative AI workflows platform that brings teams and AI together to plan, co
Xsolla and Stevenage FC Launch Charity Campaign With SpecialEffect to Make Gaming Accessible for All24.3.2026 14:00:00 CET | Press release
Donation Of 50 Accessible Setups Reinforces Xsolla’s Commitment To Inclusive Gaming Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, has partnered with Stevenage FC to launch a charity campaign with SpecialEffect in the United Kingdom, a charity dedicated to helping everyone to have the ability to enjoy video games. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324722671/en/ Graphic: Xsolla Through the Official Partnership of Stevenage FC, Xsolla is donating the kit for the April 6th match vs Blackpool. SpecialEffect will be the primary kit brand for the match and will receive a percentage of the jersey sales leading up to the match and throughout the rest of the season. Xsolla will match donations from jersey sales, with the goal of using the funds to provide up to 50 Accessible Setups to disabled gamers at the end of the 2025-2026 season, and to support programs
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