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
C.H. Robinson Launches World's First AI Technology That Continually Assesses, Improves and Operates Global Supply Chains3.6.2026 18:00:00 CEST | Press release
The newest innovation for Managed Solutions, the Lean AI Engineer, is the brain of the system As the global leader in Lean AI supply chains, C.H. Robinson has built the first AI technology designed to both operate a shipper’s global supply chain and also continuously assess and improve its performance. Now serving the company’s 4PL Managed Solutions customers, a new Lean AI Engineer works in concert with the Lean AI Planner introduced last year to create one connected system that uniquely enhances a supply chain as it runs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260520874794/en/ The Lean AI Engineer can assess an entire supply chain in 25 to 30 minutes and determine improvements before performance is impacted – compared to supply chain assessments that typically take up to four weeks and look backward at what has happened instead of what should happen. While the Lean AI Engineer delivers intel, the Lean AI Planner ma
Leading Global Brain Science Conference OHBM 2028 to Be Held in Yokohama3.6.2026 17:00:00 CEST | Press release
Yokohama has won the bid to host the 2028 Annual Meeting of the Organization for Human Brain Mapping (OHBM 2028), one of the world’s premier international conferences in brain science, further elevating the city’s presence as a global hub for international conventions and academic exchange. The meeting will take place at PACIFICO Yokohama from June 18–22 and will mark only the second time the meeting has been held in Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603787692/en/ YOKOHAMA JAPAN'S FIRST PORT OF CALL OHBM is a leading international academic society in the fields of brain imaging, neuroscience, and neurological-disease research. Its annual meeting attracts around 3,000 researchers, healthcare professionals, and industry representatives from around the world. OHBM 2028 will be organized in collaboration with the Japan Human Brain Mapping Society (JHBM, President: Yoshikazu Ugawa and Tetsuya Matsuda). The
Almarai Launches the 2026 Cycle of the World’s Largest Award for Food Security Research in Dryland Regions3.6.2026 16:31:00 CEST | Press release
The Almarai Prize - the international track of the Almarai Prize for Scientific Creativity - invites leading global research institutions and PhD‑holding scientists to nominate standout research that advances food security in dryland regions. Self‑nominations are not allowed; only PhD‑level nominators may submit, and institutions may nominate up to three projects. The prize totals USD 500,000 (SAR 1,875,000), awarded to one winning research project or institution. The 2026 cycle of the Almarai Prize, international track of the Almarai Prize for Scientific Creativity, has officially opened, calling on leading research institutions, distinguished scientists, and global experts to nominate pioneering research that advances food security in the world’s driest regions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603753914/en/ Almarai Launches the 2026 Cycle of the World’s Largest Award for Food Security Research in Dryland
Stabilizing Grids and Cutting Costs in Half: Europe Is Banking on Grid-Relevant Storage Systems3.6.2026 15:50:00 CEST | Press release
The European battery market is scaling up at record speed: According to the latest Solar+ Report from SolarPower Europe, at the end of 2025, the installed storage fleet in the EU had reached a total capacity of 40 gigawatts (GW) and a storage capacity of 77 gigawatt hours (GWh). This is an increase of over 45 percent compared to the previous year. By 2030, the study’s Solar+ scenario forecasts that capacity will quadruple to 171 GW, while storage capacity will increase eightfold to 598 GWh. As growing solar and wind capacities place increasing demands on European grids, storage systems will need to shift electricity over many hours. As a result, the average storage duration will go up from 1.9 to 3.5 hours. This represents a technological leap that underscores the need to establish more grid-relevant storage systems. Taking place in Munich from June 23–25, ees Europe will showcase how the industry is meeting this enormous demand. As Europe’s largest exhibition for batteries and energy
2026 World Cup Triggers Corporate Travel Boom in Canada and U.S.3.6.2026 15:00:00 CEST | Press release
Navan data reveals Canadian business bookings have tripled, while U.S. hotel prices spike 30% as global enterprises lock in client entertainment Navan (NASDAQ: NAVN), the global AI-powered business travel and expense management platform, today released year-over-year data revealing global enterprises are leaning in heavily to the upcoming 2026 World Cup, with hotel and flight bookings for business travel to World Cup host cities up 46% to the U.S. and a massive 295% to Canada. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602020779/en/ Navan data reveals Canadian business bookings have tripled, while U.S. hotel prices spike 30% as global enterprises lock in client entertainment “While headlines right now are focusing on softer-than-expected tourism demand and lagging leisure hotel bookings, our corporate data tells a different story,” said Dane Molter, SVP, Navan Group Travel Marketplace. “Companies are embracing the Wor
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