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
Boomi Named One of The Sunday Times Best Places to Work 202622.5.2026 08:00:00 CEST | Press release
Employee-led recognition places Boomi among the UK's top medium-sized employers, with a flight risk of just 3% against a technology sector average of 42% Boomi achieves an average employee happiness score of 86%, rated Excellent across all six dimensions of WorkL's workplace framework Flight risk of just 3%, compared to a technology sector average of 42%, reflecting exceptional levels of employee loyalty Rated Excellent for Diversity and Inclusion and Confidence in Management Boomi, the data activation company for AI, has today been named one of The Sunday Times Best Places to Work 2026 in the Medium Organisation category. The prestigious annual list, produced by The Sunday Times in partnership with global workplace analytics company WorkL, recognises the UK's finest employers based entirely on direct employee feedback, making it one of the most credible and transparent employer benchmarks in the country. This press release features multimedia. View the full release here: https://www.b
LTM Has Issued an Offer to Acquire Randstad’s Technology and Consulting Services Business in Europe and Australia to Scale Domain-Driven Solutions and AI Services22.5.2026 07:09:00 CEST | Press release
The deal would be part of a 360° partnership with Randstad involving: Proposed acquisition of USD 500M+ (€469M) business, primarily across Aerospace & Defence, Automotive, Utilities and BFS Five-year IT services partnership to drive AI-enabled transformation for Randstad’s India Global Capability Center Strategic talent MSP to support LTM’s expanding global workforce LTM and Randstad announced that LTM has issued an offer to acquire Randstad’s Technology and Consulting Servicesbusiness in France, Germany, Belgium, Luxembourg and Australia, representing USD 500+ million (€469M) in annual revenue, to scale domain-driven solutions and AI services in the region. The proposed acquisition would expand LTM’s presence in key markets, primarily across Aerospace & Defence, Automotive, Utilities and BFS. It would enable local domain expertise and complementary regional capabilities in domain-driven digital engineering, cybersecurity and IoT, supported by onshore and nearshore delivery through cen
Polpharma Biologics and Tuteur Sign Licensing Agreement for a Biosimilar for Autoimmune Diseases22.5.2026 07:00:00 CEST | Press release
Polpharma Biologics, a leading biopharmaceutical company specializing in the development and manufacturing of biosimilars, today announced the signing of a landmark licensing agreement with Argentina-based Tuteur. Under this strategic partnership, Tuteur will obtain exclusive rights to commercialize a biosimilar for autoimmune diseases across Latin America (LATAM), excluding Brazil. Polpharma Biologics will retain full responsibility for the development and manufacturing of the biosimilar. Tuteur will be responsible for commercialization, marketing, and distribution in the licensed territories. This collaboration reflects a shared commitment to expanding patient access to high-quality, affordable biological therapies across the region. “Partnering with Tuteur represents an important step in advancing our mission to broaden access to biosimilars globally,” said Anjan Selz, CEO of Polpharma Biologics. “With their strong regional expertise and commercial capabilities in LATAM, we are well
Global Stars Ahn Hyo-seop and Khalid Release New Cross-Market Single “Something Special” via FANDOM Today22.5.2026 06:00:00 CEST | Press release
Produced by Woo “RAINSTONE” Rhee and Grammy Award-Winning Producer Troy “R8DIO” JohnsonStream the Single HERE For approved imagery, please download HERE Today marks the official release of “Something Special,” the highly anticipated cross-market collaboration from international star Ahn Hyo-seop and multi-platinum recording artist Khalid, available now via FANDOM on all major streaming platforms. Stream the single HERE. Musicow will also release an official music video in June, highlighting the unique chemistry between Ahn Hyo-seop and Khalid while bringing the song’s cross-cultural collaboration to life on screen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260522928365/en/ Ahn Hyo-seop, globally recognized for his breakout role as “Jinu,” the leader of demon boy band Saja Boys in Netflix’s animated phenomenon KPop Demon Hunters, joins forces with Grammy-nominated artist Khalid for a genre-blending release that bridges t
Lenovo Group: Q4 and Full Year Financial Results 2025/2622.5.2026 01:47:00 CEST | Press release
Lenovo delivers exceptional fourth quarter results – maintaining growth and concluding strongest year in the Group’s history Lenovo GroupLimited (HKSE: 992) (ADR: LNVGY), together with its subsidiaries (‘the Group’), today reported fourth quarter and full year results for fiscal year 2025/26, marking an exceptional Q4 and the strongest year in the Group’s history. During the quarter, overall Group revenue reached an all-time fourth quarter high of US$21.6 billion, up 27% year-on-year, marking the highest year-on-year growth rate in five years, with adjusted net income[1]doubling year-on-year to US$559 million. AI-related revenue[2] stood out as a leading growth engine, growing 84% year-on-year to account for 38% of total Group revenue in Q4. For the full year, the Group delivered record revenue of US$83.1 billion, with adjusted net income growing 42% year-on-year to US$2 billion. All business groups achieved solid double-digit year-on-year revenue growth, with a notable record full-yea
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