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
Ant International Partners with Google’s Universal Commerce Protocol to Expand AI Capabilities12.1.2026 02:15:00 CET | Press release
Ant International, a leading global payment, digitisation, and financial technology provider, is collaborating on the launch of Google’s Universal Commerce Protocol (UCP), a new open standard for agentic commerce that works across the entire shopping journey — from discovery and buying to post-purchase support. UCP establishes a common language for agents and systems to operate together across consumer surfaces, businesses, and payment providers to enable commerce. So instead of requiring unique connections for every individual agent, UCP enables all agents to interact easily. UCP is built to work across verticals and is compatible with existing industry protocols like Agent2Agent (A2A), Agent Payments Protocol (AP2), and Model Context Protocol (MCP). “For agentic commerce to scale, it’s critical for the industry to align on a common set of standards. We are proud to have Ant International endorse the Universal Commerce Protocol as the foundation for that future,” said Ashish Gupta, VP
Torq Secures $140M Series D at $1.2B Valuation to Lead the AI SOC and Agentic AI Era11.1.2026 17:59:00 CET | Press release
Fueled by Massive Customer Adoption of AI Agents, Torq Scales the World’s First True AI SOC Platform and Accelerates Expansion into the U.S. Federal Market Torq, the established Agentic AI security operations pioneer, today announced it has closed a massive $140 million Series D funding round, propelling its valuation to $1.2 billion and total funding to $332M. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112510774/en/ Led by Merlin Ventures—a leading cybersecurity fund renowned for its deep access to the U.S. commercial and Public Sector markets—with participation from all existing investors, including Evolution Equity Partners, Notable Capital, Bessemer Venture Partners, Insight Ventures Partners, and Greenfield Partners, this capital injection is a definitive investment in the future of security. Torq is driving the industry’s critical shift: the complete transformation of the Security Operations Center (SOC) through
Andersen udvider sine kompetencer med tilføjelsen af Scimitar9.1.2026 21:44:00 CET | Pressemeddelelse
Andersen Consulting har indgået en samarbejdsaftale med Scimitar, der er et firma med fokus på at accelerere innovation i biovidenskabsbranchen. Scimitar, der har hovedkvarter i USA, et førende konsulenthus inden for strategieksekvering for biovidenskabsbranchen. Virksomheden er specialiseret i design af driftsmodeller, digital transformation og organisatorisk forandring. Scimitar samarbejder med medicinal- og biotech-virksomheder om at accelerere innovation, styrke den driftsmæssige eksekvering og sikre compliance gennem hele produkters livscyklus. Deres praktiske og samarbejdsorienterede tilgang sikrer løsninger, der ikke blot er formålstjenlige, men også skalerbare. "Virksomheder inden for biovidenskabsbranchen befinder sig i en tid med hurtige videnskabelige fremskridt, stigende regulatorisk kompleksitet og et voksende behov for operationel agilitet, samtidig med at de holdes op mod de højeste standarder for patientsikkerhed og dataintegritet," udtaler Ramy Khalil, CEO i Scimitar.
Biocytogen and Acepodia Expand Collaboration Through Option-based Evaluation Framework for First-in-Class Bispecific and Dual-Payload ADCs (BsAD2C)9.1.2026 13:00:00 CET | Press release
Expanded collaboration builds on Acepodia and Biocytogen’s recent co-development efforts to evaluate selected bispecific antibody and dual-payload ADC programs Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315) and Acepodia (6976:TT), today announced that the companies have entered into an option and license agreement designed to enable the structured evaluation of bispecific antibody-drug conjugate (BsADC) programs to further advance the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs). The agreement grants Acepodia an option to obtain an exclusive worldwide license from Biocytogen for two BsADC programs. Under the terms of the agreement, Biocytogen is eligible to receive an upfront option fee and, upon Acepodia’s exercise of the option, additional payments including option exercise fees, development, regulatory, and commercial milestone payments, as well as royalties on future product sales. The financial terms of the agreem
Blockstream Capital Partners Announces Strategic Acquisition of Derivatives Trading Team from Numeus Group, Leveraging Strategic Partnership with Komainu9.1.2026 11:08:00 CET | Press release
Blockstream Capital Partners (“BCP”) today announced that it has entered into a strategic agreement to acquire a division within Numeus Group’s digital asset trading and investment business. The transaction includes the absorption of select Bitcoin focused trading strategies with a focus on yield generation as well as a ten person derivatives trading team led by Chief Investment Officer Deepak Gulati, a specialist in volatility and derivatives markets. Deepak Gulati, appointed Co-Chief Investment Officer of Blockstream Capital Management alongside Rodrigo Rodriguez, previously served as Global Head of Proprietary Trading at JPMorgan, before founding Argentiere Capital, a multibillion-dollar volatility-focused hedge fund. With a thesis that derivatives would drive Bitcoin and digital asset market maturity, he co-founded Numeus Group in 2021 to develop institutional-grade trading, risk management and market-structure capabilities. Komainu, an existing BCP strategic investment, has played
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