GALDERMA
Galderma today announced the presentation of new phase 2 data supporting the efficacy of its investigational monoclonal antibody, nemolizumab, at the virtual 30th EADV congress, taking place between 28 September and 2 October 2021.
Results from two key trials of nemolizumab given every 4 weeks, demonstrate rapid onset of action and significant reduction in symptoms for patients with prurigo nodularis (PN) and atopic dermatitis (AD), and new real-world evidence highlight the PN disease burden.
|
"We are delighted to share new analyses and clinical trial data which reinforce nemolizumab’s therapeutic potential and comprehensive benefits across prurigo nodularis and atopic dermatitis. The scientific evidence for the critical role that the IL-31 pathway plays in the inflammatory process is growing and we are committed to continuing our work diligently to bring nemolizumab to patients living with these debilitating skin conditions.”
BALDO SCASSELLATI SFORZOLINI, M.D., PH.D., GLOBAL HEAD OF R&D, GALDERMA |
Nemolizumab significantly reduces itch within 48 hours in PN
Findings from a secondary analysis of a phase 2 trial evaluating the onset of action in pruritus and sleep disturbance in patients with moderate-to-severe PN were the subject of abstract #465. Within 48 hours, nemolizumab significantly reduced severe itch over three times more effectively than placebo (-19.5% vs -5.8%, respectively, p=0.014), a rapid and significant decrease in itch which was maintained for the duration of the study. At Day 4, approximately a quarter of patients were already demonstrating strong reduction in severe itch responses to treatment with nemolizumab, compared to no responses for the placebo group (23.5% vs 0%, p<0.001). At study completion (12 weeks), over 50% of PN patients demonstrated a response to nemolizumab treatment (52.9% vs. 8.3%).
At Day 4, nemolizumab led to a four times greater improvement in sleep disturbance versus placebo (-19.8% vs -4.3%, p=0.012), with benefits significantly increased through week 4.
|
"Prurigo nodularis is associated with a markedly impaired quality of life and frequent sleep deprivation. This analysis highlights nemolizumab’s rapid onset of action bringing itch reduction within 48 hours of the first dose, and a significant improvement in sleep as early as Day 4 for moderately to severely affected patients. This symptomatic relief translates into a meaningful improvement in day-to-day life for these patients.”
PROFESSOR SONJA STÄNDER LEAD INVESTIGATOR, PROFESSOR FOR DERMATOLOGY, UNIVERSITY HOSPITAL MUENSTER, MUENSTER, GERMANY |
|
Direct anti-inflammatory effect suggested for nemolizumab leading to early improvement in AD
New and consistent findings for nemolizumab in AD were also presented in abstract #1200, a secondary post-hoc analysis of the phase 2b data in adult patients with moderate-to-severe AD recently published in the Journal of Allergy and Clinical Immunology (JACI). From the first week of treatment, nemolizumab showed a significant improvement in the clinical signs and symptoms of AD, as indicated by SCORAD, increasing through week 16. This included early improvement of erythema and excoriation suggests a direct anti-inflammatory effect, whereas improved skin dryness vs placebo could be a consequence of a beneficial effect of nemolizumab on the skin barrier.
|
"This analysis is important as it points to the direct anti-inflammatory effect of nemolizumab and builds our understanding of its mechanism of action bringing rapid and profound reduction in itch sensations and skin lesions for patients living with atopic dermatitis.”
PROFESSOR JEAN-DAVID BOUAZIZ LEAD INVESTIGATOR, DEPARTMENT OF DERMATOLOGY, SAINT-LOUIS HOSPITAL, PARIS, FRANCE |
|
Marked improvements in signs and symptoms of AD also demonstrated in adolescent patients
A third abstract, #976, considered the pharmacokinetics (PK), safety and efficacy during nemolizumab treatment of AD in adolescents. AD is problematic in this age group as many activities in a teenager’s daily routine, such as sports and extracurricular events result in increased body temperature and sweating. Furthermore, as academic and social pressures increase during adolescence, anxieties and stress levels rise, worsening symptoms of AD. In patients aged 12-17 with moderate-to-severe pruritus, nemolizumab demonstrated a marked improvement in rash, itch, sleep and quality of life (QoL) and biomarkers.
About atopic dermatitis
Atopic dermatitis (AD) is a disruptive and debilitating inflammatory skin disease, characterized by diffuse skin lesions and constant disruptive itch.1,2
Reported prevalence of AD varies greatly, ranging from 1% to 25% of the population depending on the geography and age range.3
This severe and chronic skin disease can have a profound impact on patients’ quality of life, leading to sleep difficulties and causing secondary skin infections.4
About prurigo nodularis
Prurigo nodularis (PN) is a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated intense unrelenting itch.5
While PN can occur at any age, it is most likely to affect people between the ages of 40 and 69, frequently leading to severe impairment in quality of life.4
The global prevalence of PN is unknown as there are no studies describing the epidemiology of the condition. In the U.S., the latest estimate is that PN affects 52.9 people in every 100,000.4
In the European context, rates of between 0.65 and 11.1 per 10,000 population have been reported. In addition to natural variation, this relatively wide range of estimates is partly due to differences in case definition and the representativeness of the study populations.6
About nemolizumab
Nemolizumab is a first-in-class monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from neuroimmune cytokine IL-31.7
IL-31 plays a key role in multiple disease mechanisms in both atopic dermatitis and prurigo nodularis. With its unique role in directly stimulating sensory neurons related to itch and contributing to inflammation and barrier dysfunction, IL-31 is a central mediator that serves as the bridge between the immune and nervous systems while directly acting on structural cells in the skin. 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 for the treatment of atopic dermatitis and prurigo nodularis and its safety and efficacy have not been fully evaluated by any regulatory authority. Nemolizumab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of pruritus associated with prurigo nodularis.
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
References
1
Langan S. et al. Atopic dermatitis. The Lancet
. 2020;396(10247):345-360. DOI: https://doi.org/10.1016/S0140-6736(20)31286-1
2
Weidinger S. et al. Atopic dermatis. Nature Reviews.
2018. DOI: 10.1038/s41572-018-0001-z
3
Silverberg, J, I. Public Health Burden and Epidemiology of Atopic Dermatitis.283-289. 2017.
4
Atopic Eczema – Symptoms. NHS. Available from: https://www.nhs.uk/conditions/atopic-eczema/symptoms/
Accessed: March 2021
5
Galderma. Data on File.
6
Morgan LI. Christopher. Epidemiology of prurigo nodularis in England. 2021.
7
Saleem M. et al. Interleukin-31 pathway and its role in atopic dermatitis: a systematic review. J Dermatolog Treat. 2017;28(7):591-599. DOI: 10.1080/09546634.2017.1290205
View source version on businesswire.com: https://www.businesswire.com/news/home/20210928006071/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
SCENTMATIC's AI "KAORIUM" Debuts at THAMEEN Fragrance Launch in London's Selfridges4.7.2025 11:13:00 CEST | Press release
SCENTMATIC Inc., a leader in scent digitalization, introduced its AI-powered scent-to-language system, KAORIUM, at the THAMEEN Fragrance new product launch event. This pivotal event took place from June 5 to 11, 2025, at Selfridges department store in London, UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703662207/en/ State of exhibition Global Expansion: KAORIUM Establishes UK Presence Europe leads the global fragrance market, with the UK projected to reach US$2.82 billion by 2033. Recognizing this, SCENTMATIC is rapidly expanding its international footprint. In May 2024, SCENTMATIC established its overseas subsidiary, KAORIUM, in London, appointing industry expert Ben Yanoushek as CEO. Official UK operations commenced on February 1, 2025, with the launch of its dedicated website: www.kaorium.com. KAORIUM Trialed at "Florentine Diamond" Launch Event The "Florentine Diamond" launch event for luxury brand THAMEEN Frag
Andersen Consulting samarbejder med Mercurial Minds om at forbedre mulighederne inden for digital transformation4.7.2025 01:10:00 CEST | Pressemeddelelse
Andersen Consulting udvider sit udbud af teknologidrevne løsninger med tilføjelsen af samarbejdsfirmaet Mercurial Minds (M.M.), et konsulentfirma inden for digital transformation, AI og IT med base i Pakistan. M.M. blev grundlagt i 2013 og tilbyder en række tjenester, der er designet til at hjælpe organisationer med at udvikle sig og skalere, herunder i forbindelse med deres digitale transformationsstrategi, AI-tjenester, it-rådgivning og udvikling af robuste mobil- og webbrugeroplevelser. Firmaet leverer end-to-end-løsninger – udformning af datadrevne køreplaner, udvikling af intelligent automatisering og levering af sikre mobil- og weboplevelser, der kan skaleres – skræddersyet til virksomheder, der ønsker at forbedre sine forbindelsesmulighederne og opnå indsigter i realtid. M.M. betjener en bred vifte af brancher med fokus på finans, telekommunikation og andre dataintensive sektorer. "Dette samarbejde er en katalysator," siger Nabeel Saiyer, administrerende direktør for M.M. "Vores
Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 01:00:00 CEST | Press release
The World Economic Forum report, in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, predicts a significant uptick in tourist trips across the globeThe tourism sector will contribute $16 trillion to global GDP (more than 11% of the global economy) by 2034, according to World Travel & Tourism Council estimates (WTTC)India and China will be responsible for more than 25% of all outbound travel by 2030 The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster th
The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 21:00:00 CEST | Press release
The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate
Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 14:59:00 CEST | Press release
Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac
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