GALDERMA
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
NTT DOCOMO BUSINESS and NTT Com Asia Launch “APN InterLink” Service in Hong Kong24.10.2025 06:00:00 CEST | Press release
Transforming the Financial Services Industry with IOWN® Infrastructure NTT DOCOMO BUSINESS, Inc. (formerly NTT Communications Corporation, hereafter “NTT DOCOMO BUSINESS”) and its Hong Kong subsidiary, NTT Com Asia, today announced the launch of the “APN InterLink” service in Hong Kong for financial institutions starting November 1, 2025, leveraging All-Photonic Network (APN)*1 technology in support of the IOWN®*2 initiative. Commercially deployed in Hong Kong, one of the leading Asia financial hubs, the new service leverages ultra-low latency photonics-based connectivity to address the evolving digital needs of the financial sector, especially for latency-sensitive trading, algorithmic trading*3, proximity market data access and real-time transaction. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251023916941/en/ NTT APN InterLink Service Looking ahead, NTT DOCOMO BUSINESS and NTT Com Asia plan to expand the deployment of
Hanshow Wins the Technology Vendor of the Year at 2025 RTIH Innovation Awards in London24.10.2025 05:00:00 CEST | Press release
Hanshow, a global leader in digital retail solutions, has been honoured at the 2025 Retail Technology Innovation Hub (RTIH) Innovation Awards, winning the Technology Vendor of the Year title for its pioneering shelf marketing solution. The recognition underscores Hanshow’s commitment to redefining how retailers and brands engage with shoppers through NFC-enabled ESLs that seamlessly connect physical stores with digital engagement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251023122859/en/ The RTIH Innovation Awards are widely regarded as one of the most influential recognitions in the global retail technology sector. Each year, the awards celebrate organisations driving innovation, digital transformation, and operational excellence in a fast-moving omnichannel world. The 2025 ceremony, held at The HAC in central London, brought together senior retail executives, technology innovators, and thought leaders shaping the fut
DNIB.com Reports Internet Has 378.5 Million Domain Name Registrations at the End of the Third Quarter of 202523.10.2025 23:00:00 CEST | Press release
VeriSign, Inc. (NASDAQ: VRSN), a global provider of critical internet infrastructure and domain name registry services, today announced that, according to the latest Domain Name Industry Brief Quarterly Report from DNIB.com, the third quarter of 2025 closed with 378.5 million domain name registrations across all top-level domains (TLDs), an increase of 6.8 million domain name registrations, or 1.8% compared to the second quarter of 2025. Domain name registrations also increased by 16.2 million, or 4.5%, year over year. The .com and .net TLDs had a combined total of 171.9 million domain name registrations in the domain name base at the end of third quarter of 2025, an increase of 1.4 million domain name registrations, or 0.8% compared to the second quarter of 2025. The .com and .net TLDs had a combined increase of 2.4 million domain name registrations, or 1.4%, year over year. As of Sept. 30, 2025, the .com domain name base totaled 159.4 million domain name registrations and the .net do
Copeland Expands Industrial Heat Pump Portfolio with Agreement to Acquire SPH Sustainable Process Heat23.10.2025 22:30:00 CEST | Press release
Acquisition enhances Copeland’s industrial heating portfolio Copeland, a global leader in sustainable climate solutions, today announced its agreement to acquire SPH Sustainable Process Heat (SPH), a Germany-based industrial heat pump technology company. This acquisition is expected to expand Copeland’s industrial heating portfolio, allowing the company to deliver a broader range of key heat pump technologies and solutions to new and existing customers. Copeland’s industrial business operates under the brand name Vilter. SPH will continue to operate independently until closing. This acquisition reinforces Copeland’s commitment to enabling the energy transition, in this case, through innovative technologies that enable industrial customers to replace fossil-fuel systems with more energy-efficient heating alternatives. SPH brings a strong technology portfolio, including its innovative ThermBooster™ technology, and demonstrated capability in delivering solutions to a broad range of indust
NIQ Publishes 2025 ESG Progress Report: Advancing Integrity, Innovation, and Impact23.10.2025 22:05:00 CEST | Press release
NIQ (NYSE: NIQ), a leading consumer intelligence company, today released its 2025 Environmental, Social, and Governance (ESG) Progress Report, covering its progress in 2024 and underscoring the company’s commitment to responsible business, data integrity, and inclusive growth across its global operations. “As a leading consumer intelligence company, our responsibility extends far beyond the industries we serve,” said Jim Peck, Executive Chairman and CEO of NIQ. “This year’s ESG Progress Report demonstrates how we are embedding sustainable and inclusive principles into our business, driving value for our clients, investors, associates, and communities.” Key progress areas from 2024Strengthened ESG governance: NIQ formalized its internal ESG governance framework and initiated a Double Materiality Assessment, aligning with the latest global standards and regulations. Advanced data integrity and security: The company advanced its use of AI and machine learning to ensure data quality, priva
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