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
70% of Enterprise AI is Uncontrolled, Driving Hidden Risk, Cost and Slower ROI27.4.2026 10:00:00 CEST | Press release
Lenovo research highlights a growing AI execution gap as organizations struggle to control and operate AI across their environments AI is already being used across your organization, whether it has been formally approved or not. Employees are using AI with or without IT involvement, fueling the rise of ‘shadow AI’ across the enterprise, creating gaps in governance and control. This is no longer just an IT challenge. For Chief Information Security Officers, this shift is expanding the attack surface across devices, endpoints, and data flows, introducing unmanaged risk and increasing the likelihood of sensitive company data being exposed or accessed without proper controls. What this reveals is a growing AI execution gap: usage is accelerating, but control is not keeping pace. Based on a survey of 6,000 employees worldwide, Lenovo’s latest Work Reborn Report, Leading Your Workforce to Triumph with AI, finds that more than 70% of employees are using AI weekly, with up to one third operati
First Enterprise Quantum Computer Purchase in Japan: IQM to Deploy System to TOYO Corporation27.4.2026 08:00:00 CEST | Press release
First enterprise quantum computer purchase in Japan cements IQM's position as the global leader in deployed quantum computers The Radiance 20-qubit system will enable TOYO to explore various industry use cases, while advancing a hybrid quantum-HPC infrastructure. This will be the third quantum computer to be deployed by IQM in the Asia-Pacific region. IQM Quantum Computers, the global leader in superconducting quantum computers, today announced the purchase of its full-stack 20-qubit quantum computer by TOYO Corporation, marking the first enterprise quantum system deployment in Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260426053944/en/ (From Left): Toshiya Kohno, Representative Director, President and CEO of TOYO Corporation, and Jan Goetz, CEO & Co-founder of IQM Quantum Computers. The Radiance 20-qubit system will be made available in both on-premises and cloud environments and will be delivered by the end of 2
SAP and S3NS Accelerate Trusted Cloud Adoption in France With Thales as First Strategic Customer27.4.2026 08:00:00 CEST | Press release
Thales adopts SAP RISE private cloud edition on S3NS to transform its ERP (Enterprise Resource Planning) landscape and operationalize digital sovereignty at scale. By combining SAP’s enterprise applications and Business AI capabilities with S3NS’s trusted infrastructure, this partnership unlocks cloud adoption for highly regulated sectors, including public administration, aerospace and defense, and operators of vital and essential services. Thales (Euronext Paris: HO): This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260426644177/en/ Strategic partnership (c)S3NS A decisive step in scaling trusted cloud in Europe The strategic partnership between SAP and S3NS, the trusted cloud provider established by Thales and Google Cloud, will strengthen trusted cloud capabilities in France and support Europe’s growing demand for cloud business transformation. SAP RISE private cloud edition will be deployed by SAP Sovereign Cloud on S3NS’
Murata Launches Ultra-Low Power AMR Sensors to Boost Battery Life in Healthcare and Wearables Devices27.4.2026 04:00:00 CEST | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has commenced mass production of its MRMS166R and MRMS168R anisotropic magnetoresistance (AMR) sensors for healthcare, wearable, and IoT devices. The MRMS166R is the first AMR sensor to combine an average current consumption of 20 nA with operation from a 1.2 V supply, enabling extended battery life in coin cell-powered systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260413296947/en/ [Murata Manufacturing Co., Ltd.] AMR sensor The devices are solid-state magnetic sensors used for switching applications. They detect the presence or absence of a magnetic field and generate an output signal that system logic uses to control functions such as transitions between active and sleep modes. This enables contactless switching without mechanical components, improving reliability, and supporting sealed, miniaturized designs. Automatic switching between active and
Sun Pharma signs Definitive Agreement to Acquire Organon27.4.2026 01:51:00 CEST | Press release
Organon stockholders to receive US$ 14.00 per share in cashThe deal values Organon at EV of US$ 11.75 billionCombined Business leverages complementary portfolios and global scale for sustained long‑term value creation Sun Pharmaceutical Industries Limited(Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) (together with its subsidiaries and/or associated companies, “Sun Pharma”) and Organon & Co. (NYSE: OGN) (“Organon”) today announced that they have entered into a definitive agreement under which Sun Pharma will acquire all outstanding shares of Organon for US$ 14.00 per share in an all‑cash transaction with an enterprise valuation of US$ 11.75 billion. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260426881370/en/ Organon is a global healthcare company formed through a spinoff from Merck, known as MSD outside of the United States and Canada, in 2021. Organon has a legacy of deep trust and strong brand equit
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