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
4th Digital Engineering Awards Celebrate Global Innovators, AI Trailblazers: Herald the Rise of Engineering Intelligence14.3.2026 17:46:00 CET | Press release
Developed in association with ISG and CNBC-TV18, the fourth edition draws more than 250 nominations from 90+ global companies The Digital Engineering Awards concluded its fourth edition at Boston, Massachusetts on Thursday, honoring technology pioneers and organizations for their contributions to technology solutions and AI advancements. The gala night presented by L&T Technology Services (BSE: 540115, NSE: LTTS) along with ISG as the knowledge and research partner and CNBC-TV18 as the media partner, hosted both industry leaders and individual changemakers from 17 countries across North America, Europe, and the rest of the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260314443410/en/ The 4th edition of the Digital Engineering Awards, in association with ISG, CNBC-TV18 and L&T Technology Services, drew more than 250 nominations from 90+ global companies A total of 258 nominations from leading organizations and engine
Venture Global Announces Final Investment Decision and Financial Close for Phase 2 of CP2 LNG13.3.2026 15:23:00 CET | Press release
$8.6 billion project financing for CP2 Phase 2 brings project’s total financing to $20.7 billionProject expected to make Venture Global the largest exporter of US LNGUnprecedented milestone of five FIDs in less than 7 years, with over $95 billion in capital markets transactions Today, Venture Global, Inc. (NYSE: VG) is announcing a final investment decision (FID) and successful closing of an $8.6 billion project financing for the second phase of the company’s third project, Venture Global CP2 LNG (CP2). When combined with the Phase One financing for CP2 announced July 2025, this milestone represents the largest standalone project financing in the U.S. bank market.The transaction garnered enormous interest from the world’s leading banks, resulting in over $19 billion of commitments for Phase Two in addition to the previous $34 billion of commitments for Phase One, and required no outside equity investment. “We are extremely proud to have taken FID on the second phase of CP2, our third g
NIQ Launches Beta of New AI-Powered Analytical Capabilities in Ask Arthur13.3.2026 12:00:00 CET | Press release
AI-guided analysis helps brands and retailers turn data into decision-ready insights NIQ (NYSE: NIQ), a global leader in consumer intelligence, has launched new AI-powered analytical capabilities in beta within Ask Arthur on the NIQ Discover platform. The expanded experience guides users through end-to-end analysis—helping them identify what matters in the data, understand why trends are occurring, and turn insights into clear, shareable narratives with recommended next steps. As organizations navigate increasing data complexity, the ability to move quickly from insight to action has become essential. Ask Arthur helps shorten analytical processes that once took days or weeks into minutes by surfacing the key drivers behind performance changes and generating decision-ready insights directly within Discover. By connecting analysis, explanation, and storytelling in a single experience, users can move seamlessly from understanding what is happening in the data to determining what to do nex
Reply at NVIDIA GTC: Digital Twins and Physical AI Driving the Next Stage of Industrial Value Creation13.3.2026 11:24:00 CET | Press release
Reply [EXM, STAR: REY] will be present at NVIDIA GTC from 16 to 19 March 2026 in San Jose, California, showcasing how companies can optimise production and logistics processes, scale robotics and sustainably increase industrial performance using digital twin technology and physical AI. The conference is regarded as the most important international meeting point for AI developers, researchers and decision makers. This year, more than 30,000 participants from over 190 countries are expected to attend. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260313000399/en/ By attending NVIDIA GTC, Reply is showcasing how digital simulation and physical automation are already being integrated in practice. Projects for the Otto Group and the industrial edge domain show how physical AI and precise digital twins work together to create new opportunities for industrial value generation. The focus will be on two concrete use cases that demon
Klarna Board Chair Michael Moritz Acquires 3.47 Million Shares for $50 Million13.3.2026 11:05:00 CET | Press release
Klarna Group plc (NYSE: KLAR) today discloses the following transactions by the Chair of its Board of Directors and Chief Product & Design Officer, filed with the U.S. Securities and Exchange Commission on Form 3. Share Purchases Michael Moritz, Chairman, through an associated entity, purchased 3,472,845 ordinary shares between March 3 and March 11, 2026, at an aggregate consideration of $49,913,138.73. David Fock, Chief Product & Design Officer, purchased 27,000 ordinary shares on March 9, 2026, for an aggregate consideration of $388,552.14. Share Sales David Sandström, Chief Marketing Officer, sold 32,703 shares on March 9, 2026, pursuant to a Rule 10b5-1 trading plan, established in 2025. David Sykes, Chief Commercial Officer, sold 23,799 shares on March 13, 2026, pursuant to a separately established Rule 10b5-1 trading plan, established in 2025. Form 3 filings for all transactions are available on the SEC's EDGAR database atwww.sec.gov. Forward-Looking Statements This press release
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