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
Agenus Reports 48% Estimated Three-Year Survival With BOT+BAL in Recurrent Ovarian Cancer at IGCS 20263.10.2026 16:50:00 CEST | Press release
Survival estimate remained at 48% between years two and three, extending evidence of durable benefitResults observed in heavily pretreated, difficult-to-treat population that received a median of four prior lines of therapy; nearly three-quarters of patients had platinum-resistant or refractory cancer Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced three-year follow-up results from the ovarian cancer cohort of its 400+ patient Phase 1b C-800-01 trial. The study evaluated botensilimab (BOT), Agenus’ multifunctional, Fc-enhanced anti-CTLA-4 antibody, in combination with balstilimab (BAL), Agenus’ anti-PD-1 antibody. The results, including three-year survival and outcomes by sensitivity to platinum-based chemotherapy and by prior treatment, were presented at the 2026 International Gynecologic Cancer Society (IGCS) Annual Global Meeting in Montréal, Canada. Among patients evaluable for efficacy, three-year overall survival was 48% (n=35), unchanged from
Andersen Global udvider sin juridiske virksomhed i Pakistan med et nyt medlemsfirma2.10.2026 22:36:00 CEST | Pressemeddelelse
Andersen Global styrker sin juridiske tilstedeværelse i Pakistan, idet Samdani & Qureshi, der har været samarbejdspartner siden 2021, skifter navn til Andersen Legal in Pakistan og bliver den seneste medlemsvirksomhed, der slutter sig til organisationen. Andersen Legal in Pakistan har hovedkontor i Islamabad og rådgiver både indenlandske og internationale klienter, herunder virksomheder, investorer, finansielle institutioner, offentlige enheder, udviklingsorganisationer og privatpersoner, om juridiske, kommercielle og regulatoriske forhold. Firmaet arbejder også med voldgift og tvistbilæggelse og rådgiver om komplekse transaktioner, investeringer, finansiering, projekter og tvister i Pakistan og på tværs af landegrænser. "Vores tilgang bygger på stærkt engagement fra ledelsen, klar kommunikation og disciplineret analyse med fokus på at levere rådgivning, som vores klienter kan omsætte til handling," sagde Nudrat Ejaz Piracha, partner hos Andersen Legal in Pakistan. "Ved at blive en del
emnify Appoints Sacha Herrmann as Chief Financial Officer and Christian Friis as Chief Revenue Officer2.10.2026 17:12:00 CEST | Press release
Appointments expand emnify executive team to accelerate global growth emnify, a global leader in IoT connectivity, today announced the appointments of Sacha Herrmann as Chief Financial Officer and Christian Friis as Chief Revenue Officer, effective immediately. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261001902751/en/ emnify Appoints Sacha Herrmann as Chief Financial Officer and Christian Friis as Chief Revenue Officer The appointments follow the recent naming of Kenneth De Spiegeleire as Chief Executive Officer and Frank Stoecker as Executive Chairman of the Board. Together, these leadership changes strengthen emnify financial, operational, and commercial capabilities as the company enters its next phase of international growth. “We have proven momentum. Our ambition is to now turn it into global category leadership,” said Kenneth De Spiegeleire, CEO of emnify. “That requires sharper focus, disciplined execution, and
Tacton Appoints Former IFS Executive Merlin Knott as Chief Commercial Officer to Accelerate Global Growth and Scale Beyond CPQ2.10.2026 15:00:00 CEST | Press release
Enterprise software veteran to lead Tacton’s united commercial organization and partner expansion worldwide. Tacton, a global leader in Configure, Price, Quote (CPQ) software and configuration solutions for manufacturers of complex products, today announced the appointment of Merlin Knott as Chief Commercial Officer (CCO). In this role, Knott will lead Tacton’s global commercial organization, including marketing, sales, and pre-sales, aligning the teams responsible for bringing Tacton’s solutions to market, and driving value to its customers and partners globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261002794882/en/ Merlin Knott, Chief Commercial Officer, Tacton Knott joins Tacton with decades of experience building and scaling commercial organizations across the enterprise software industry. Most recently, he held senior leadership roles at IFS, the world’s leading provider of Industrial AI software, where he led
EDW Presents 2026 Data Quality Award to Repeat Winner Domivest2.10.2026 15:00:00 CEST | Press release
European DataWarehouse (EDW) presented its fifth annual Data Quality Award at the 2026 TSI Congress in Berlin. This year, EDW's Best Data Quality – Deal of the Year (2026) award was presented to Domivest B.V. for its transaction Domi 2023-1 B.V., recognising the firm's outstanding commitment to accurate, complete, and consistent reporting. The award is based on EDW's proprietary data quality scoring methodology, which evaluates transactions against thousands of validation rules and checks. Data quality excellence is not a one-off achievement. The fact that the same issuers continue to rank among the top performers year after year demonstrates that superior data quality is the result of sustained commitment, robust processes, and ongoing investment. "Receiving the Data Quality Award for a second time means a great deal to us. Transparent, accurate loan-level data is key to investor trust in our transactions, and we are grateful to European DataWarehouse for recognising the work our trea
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