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
Mainstay Medical Announces Two-Year Outcomes from RESTORE Clinical Trial of ReActiv8®3.9.2026 22:30:00 CEST | Press release
ReActiv8® Restorative Neurostimulation™ treatment group showed sustained improvements in measures of disability, pain and quality of life from the one-year to the two-year timepoints.83% of control group patients elected to cross over and receive ReActiv8 therapy after the one-year assessment.After one year of ReActiv8 therapy, the outcomes in the crossover group were indistinguishable from the treatment group at the same time point, confirming the effect is reproducible, robust, and not cohort specific. Mainstay Medical Holdings plc today announced the publication of the two-year assessment results from the RESTORE randomized clinical trial of ReActiv8 for the treatment of intractable chronic low back pain. The data show continued improvements in back pain-related disability, pain and quality of life in the ReActiv8 treatment group, and improvements after one year of ReActiv8 therapy in the crossover group that were indistinguishable from the improvements shown by the treatment group
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)3.9.2026 22:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to thirty-one newly hired non-executive employees. The equity awards were granted on September 1, 2026 and consisted of options to purchase an aggregate of 280,600 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 133,500 shares. The options have an exercise price per share equal to $13.24, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restr
Lenovo Advances Hybrid AI Across New Personal and Enterprise Technology3.9.2026 18:00:00 CEST | Press release
Lenovo announces expanded Lenovo and Motorola Qira experiences and availability, new Yoga, Idea, Think, and Motorola devices, and concepts that explore the next era of more personal, connected technology. Today at Lenovo™ Innovation World during IFA 2026, Lenovo unveiled a new portfolio of personal and enterprise technology, showing how its Hybrid AI strategy is moving from vision to practical experiences across devices, infrastructure, services, and the everyday moments that connect them. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903555953/en/ Lenovo Innovation World at IFA 2026 The announcements bring together Lenovo’s “one personal AI, multiple devices” approach with enterprise technology that helps organizations turn data into insights and value. They span personal AI across PCs, smartphones, tablets, and wearables; creator and consumer devices that adapt to different ways of working and expressing ideas; and bus
Bahrain Signs its Participation Contract for Expo 2030 Riyadh3.9.2026 17:45:00 CEST | Press release
The Kingdom of Bahrain has signed its Participation Contract for Expo 2030 Riyadh, marking a new phase in preparations for its participation in the World Expo. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903144412/en/ His Excellency Sheikh Khalifa bin Ahmed Al Khalifa, President of the Bahrain Authority for Culture and Antiquities, and Talal Al-Marri, Chief Executive Officer of Expo 2030 Riyadh, at the ceremony. The agreement provides the formal framework for Bahrain’s participation in Expo 2030 Riyadh, enabling preparations to advance across the key organizational and operational aspects of its presence throughout the six-month event, including the development of its pavilion, programmes and visitor experiences. The Participation Contract was signed in Bahrain by Talal Al-Marri, Chief Executive Officer of Expo 2030 Riyadh, on behalf of Expo 2030 Riyadh, and His Excellency Sheikh Khalifa bin Ahmed Al Khalifa, President
Kaltura and Verimatrix Partner to Strengthen Security for OTT and Cloud TV Services3.9.2026 17:45:00 CEST | Press release
Partnership combines Kaltura's Cloud TV platform with Verimatrix's content protection and anti-piracy solutions, with full migration of customers to be carried out in the coming months. Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260903384589/en/ Kaltura (Nasdaq: KLTR), the Agentic Digital Experience company, and Verimatrix (Euronext Paris: VMX), a leading provider of security solutions for a safer connected world, today announced a strategic partnership designed to provide enhanced protection for OTT and Cloud TV services. The partnership brings together Kaltura's scalable Cloud TV platform and Verimatrix's Digital Rights Management (DRM) and security capabilities. The joint solution, as part of Kaltura’s Marketplace, helps Telco’s, broadcasters, and media companies securely deliver premium live and on-demand content across a wide range of devices and operating systems. Demand for advanced content protec
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