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
DC Secretary Announces Annual Determinations Committees Outcome29.4.2026 15:36:00 CEST | Press release
DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 29, 2026. Global Dealer Voting Members (for all Regions): Non-Dealer Voting Members (for all Regions): Bank of America, N.A. Citadel Americas LLC Barclays Bank plc Elliott Investment Management L.P. BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Regional Dealer Voting Member for the Americas, EMEA, Asia Ex-Japan, and Japan Determination Committees: CCP Members for the Americas, EMEA, Asia Ex-Japan, and Australia-New Zealand Determinations Committees: Mizuho Securities Co., Ltd. ICE Clear Credit LLC LCH S.A. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommitte
Driscoll's Names Wyard Stomp Chief Operating Officer and Expands Shaily Sanghvi's Role to Lead Global Strategy29.4.2026 15:00:00 CEST | Press release
Leadership announcements advance Driscoll's global ambition to scale its proven mission of delighting consumers to every market worldwide Driscoll's, the world's leading berry brand, today announced two leadership appointments to support CEO Soren Bjorn's long-term strategy to scale the company's proven, flavor-first business model globally, bringing the same deliberate approach that made Driscoll's the #2 retail food and beverage brand in the United States to consumers in every market the company serves. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429432633/en/ Wyard Stomp has been appointed Chief Operating Officer (COO), a newly created role, while continuing to lead Driscoll's Europe, Middle East, and Africa (EMEA) business. As COO, Stomp will partner closely with the Executive Leadership Team to turn strategy into action, lead cross-functional initiatives, and ensure the company executes at the pace required to sup
Boomi Builds Analyst Momentum Across Integration, API Management, Data Management, and Agentic AI29.4.2026 15:00:00 CEST | Press release
Recent analyst recognitions highlight Boomi’s expanding role in helping enterprises activate trusted data, govern APIs, and operationalize AI at scale Boomi, the data activation company, today announced continued analyst recognition across multiple strategic technology categories, underscoring the company’s momentum as enterprises look for a unified foundation to connect data, applications, APIs, automation, and AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429987428/en/ Boomi Builds Analyst Momentum Across Integration, API Management, Data Management, and Agentic AI Over the past several months, Boomi has been recognized across integration, API management, data management, and agentic AI-related categories. The company was named a Leader and positioned highest for Ability to Execute in the 2026 Gartner® Magic Quadrant™ for Integration Platform as a Service, marking Boomi’s 12th consecutive year as a Leader. Boomi wa
CSC Urges Enterprises Evaluate Applying for .BRAND Domains to Navigate AI-Driven Domain Threats and Opportunities29.4.2026 15:00:00 CEST | Press release
Upcoming gTLD registration period offers rare opportunity to gain exclusive control over domain infrastructure to mitigate third-party domain risks and AI-driven domain attacks CSC, an enterprise-class domain registrar and world leader in mitigating brand, fraud, domain, and domain name system (DNS) threats, today announced a new program to coincide with ICANN’s new Generic Top-Level Domain (gTLD) application window and to support enterprises submitting a .BRAND TLD application between April 30 and August 12, 2026. Owning a .BRAND domain gives an organization exclusive control over its entire domain infrastructure, mitigating third-party lookalike domain registrations that lead to phishing and domain spoofing. This will be the first time ICANN has opened applications for new gTLDs, including .BRANDs, since the inaugural round in 2012. There is no known date for a third window opening. As the largest provider of these domain services globally, CSC manages more than one-third (160+) of a
Dubai Records the World’s Lowest Electricity Customer Minutes Lost at Just 49 Seconds Per Year29.4.2026 14:47:00 CEST | Press release
DEWA sets a new world record for service continuity HE Saeed Mohammed Al Tayer, MD & CEO of Dubai Electricity and Water Authority (DEWA), announced that DEWA has set a new world record for the lowest electricity customer minutes lost (CML), at just 0.82 minutes (about 49 seconds) per year. With this significant achievement, DEWA has surpassed its own previous world record of 0.94 minutes in 2024, representing an improvement of around 13%. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429386479/en/ Dubai records the world’s lowest electricity customer minutes lost at just 49 seconds per year (Photo: AETOSWire) “We work in line with the vision and directives of His Highness Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and Ruler of Dubai, to provide the best electricity and water infrastructure in the world. We utilise the latest technologies of the Fourth Industrial Revolution, partic
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