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
Hollywood Chamber of Commerce Expands Into Luxury Hospitality20.7.2026 18:30:00 CEST | Press release
Hollywood Hotels & Residences to Bring the Spirit of Hollywood to Luxury Destinations Worldwide The Hollywood Chamber of Commerce, known for the iconic Hollywood Sign® and Hollywood Walk of Fame®, is expanding into luxury hospitality through a strategic partnership with The Scene Hotels & Resorts to launch Hollywood Hotels & Residences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720026178/en/ The Scene Hotels & Resorts, with 40+ years of combined expertise in hospitality, travel, and brand development, will lead the brand’s development and management. The partnership will bring the Hollywood lifestyle to luxury hotels and branded residences around the world, creating immersive destinations inspired by the world's entertainment capital. "This partnership represents far more than an expansion of the Hollywood brand—it reflects our vision of Hollywood as the world's premier hub for entertainment, creativity, and commerce
Andersen Consulting udvider med samarbejdsfirmaet Smartbridge20.7.2026 17:54:00 CEST | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med Smartbridge, et Texas-baseret firma, der tilbyder digitale løsninger og AI-teknologi, og forbedrer dermed sine kapaciteter inden for data og analyse samt digitale transformationstjenester. Smartbridge blev grundlagt i 2003 og hjælper organisationer med at accelerere deres digitale transformation og modernisere driften gennem digital innovation, AI, data og analyse samt applikationsmoderniseringstjenester. Firmaet arbejder med kunder inden for olie- og gas-, medtech- og restaurationsbranchen og kombinerer rådgivnings- og teknologitjenester for at muliggøre erhvervsvirksomheders transformation og vækst. Ved at udnytte strategiske relationer med førende teknologileverandører hjælper Smartbridge organisationer med at forbinde data, forbedre beslutningstagning og accelerere forretningsresultater. "I dag ønsker organisationer at accelerere deres digitale omstilling og AI-transformation og søger praktiske måder at omsætte innovation til m
Epic Flight Academy Agrees to Purchase up to 50 Pipistrel Voyager Aircraft, Supplementing Its Fleet of Trainers as It Supports Continued Pilot Training20.7.2026 17:38:00 CEST | Press release
Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today announced Epic Flight Academy as the launch customer for the Pipistrel Voyager during Textron Aviation’s press conference at EAA AirVenture 2026. The company has signed a purchase agreement for up to 50 Voyager aircraft, with an order for 10 initial deliveries beginning in 2027, and options for up to 20 additional aircraft in 2028 and 20 in 2029, supporting the continued expansion of its training fleet and growing demand for pilot training. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720003143/en/ Epic Flight Academy agrees to purchase up to 50 Pipistrel Voyager aircraft, supplementing its fleet of trainers as it supports continued pilot training (Photo Credit: Pipistrel, a Textron Inc. company and an affiliate of Textron Aviation Inc.) Epic Flight Academy is a Florida-based flight training provider offering FAA Part 141 and
New Pipistrel Voyager Brings Next Generation Training Capabilities and Access to Flight Schools20.7.2026 15:00:00 CEST | Press release
Debuting at EAA AirVenture 2026 in Oshkosh, the world’s largest aviation gathering Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today introduced the Pipistrel Voyager, a next-generation training aircraft designed to expand capability for flight schools while maintaining the efficiency and simplicity owners and operators expect from Pipistrel. Purpose-built for evolving pilot training requirements, the Voyager is designed to align with anticipated Modernization of Special Airworthiness Certification (MOSAIC) regulations. This positions the aircraft to support broader training missions while improving access to pilot development. The aircraft is expected to enter into service in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720673571/en/ New Pipistrel Voyager brings next generation training capabilities and access to flight schools (Photo Credit: Pipistrel, a Textron Inc. c
86% Of Enterprises Have Deployed AI Agents. Just 34% Trust Them, Boomi Study Finds.20.7.2026 15:00:00 CEST | Press release
Boomi-commissioned independent study finds integration, not smarter models, separates enterprises that trust their AI agents from those stuck in “agentic chaos” Boomi, the data activation company for AI, today announced new research conducted by Forrester Consulting on behalf of Boomi showing that despite rapid enterprise adoption of AI agents, trust hasn't kept pace with ambition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720652115/en/ Boomi-commissioned independent study finds integration, not smarter models, separates enterprises that trust their AI agents from those stuck in “agentic chaos” The Forrester survey of 409 director-and-above IT and technology decision-makers across North America, Europe, and APAC found that 86% of organizations have moved beyond the AI agent pilot stage, yet just 34% say they trust the actions their AI agents are taking. Among organizations in a state of "agentic chaos" (the bottom qu
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