Business Wire

Galderma Presents New Nemolizumab Data at EADV Reinforcing Rapid Onset of Action and Consistent Relief of Symptoms for People With Prurigo Nodularis and Atopic Dermatitis

Share

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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Investor and Media Relations
Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41-76-315-26-50

Media Contact
Lauren Starr
Head of Franchise Communications
media@galderma.com
+41-79-771-52-45

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Total Telecom: Leveraging Technology Innovation for Building Energy Efficiency 5G Networks20.10.2021 09:00:00 CEST | Press release

Total Telecom attended Huawei’s Better World Summit (BWS) for Green ICT for Green development in Dubai in United Arab Emirates (UAE), found out that the ICT industry, which is a backbone of the modern-day global economy, must adopt green and energy-efficient practices and products and take the lead in correcting the course of the climate change crisis. Huawei is at the forefront to reduce our new carbon emissions and has taken several initiatives to bring down its own carbon emissions. "With our innovative products and solutions, we want to work with customers and industry partners to jointly define industry standards, and help operators better measure and manage their carbon reduction roadmaps," says Bob Cai, Chief Marketing Officer at Carrier Business Group, while opening the Summit. The company is not just taking measures to reduce its carbon emissions but is also pursuing innovations to make telecom networks more sustainable and energy-efficient. Cai further elaborated that the ICT

FourKites Expands its Market-Leading Ocean Visibility Platform with Industry-First Dynamic ETA ® for Ocean Shipping and New Tools to Manage Demurrage and Detention20.10.2021 08:30:00 CEST | Press release

FourKites®, the world’s leading real-time supply chain visibility platform, today introduced Dynamic ETA® for Ocean, a new AI-powered innovation as part of its Dynamic OceanSM offering. The new enhancement provides shippers, carriers and 3PLs with the market’s most accurate estimated times of arrival (ETAs) for 100% of their ocean shipments across all lanes worldwide. In addition, the company has rolled out new capabilities for monitoring and mitigating demurrage and detention risks. With these new enhancements, FourKites now provides the most advanced and robust solution on the market for real-time and predictive ocean visibility, exception management and cost controls. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019006198/en/ FourKites Expands its Market-Leading Ocean Visibility Platform with Industry-First Dynamic ETA® for Ocean Shipping and New Tools to Manage Demurrage and Detention (Photo: Business Wire) These po

Evasc Neurovascular Announces the New eCLIPs Bifurcation Flow Diverter20.10.2021 07:00:00 CEST | Press release

Evasc Neurovascular is proud to announce the third generation of its eCLIPs™ device, the eCLIPs Bifurcation Flow Diverter. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019006102/en/ The third generation of Evasc's eCLIPs™ device, the eCLIPs Bifurcation Flow Diverter. The new device is classified as a flow diverter, with a leaf density of 35%, which is 60% higher than the existing eCLIPs devices. As a result, the new eCLIPs Bifurcation Flow Diverter does not require coiling and provides for the same unique neck bridging delivery. The new eCLIPs Bifurcation Flow Diverter can cover up to a 6mm neck length. The eCLIPs Bifurcation Flow Diverter also simplifies deployment with greatly reduced delivery times. “We’re excited to see the latest innovation in Evasc Neurovascular’s eCLIPs devices, which will lead to better outcomes for patients and remarkable device delivery time—usually within 10 minutes,” said Leif Sorensen, Neur

Breaking the Silence in Osteoporosis20.10.2021 07:00:00 CEST | Press release

A new international survey of 1,008 women with osteoporosis from six countries, launched on World Osteoporosis Day, reveals that while more than two-thirds (67%) of women over the age of 55 mostly understand what osteoporosis is and the potential negative impact of future fractures, 19% felt poorly informed at the time of the diagnosis.1 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019005894/en/ The survey initiated by Theramex in cooperation with the International Osteoporosis Foundation (IOF), was conducted in Germany, France, Italy, Spain, Australia, and Brazil. It included 316 postmenopausal women over the age of 55 years and 315 premenopausal women (40-55 years) with osteoporosis (altogether 62% of the surveyed women). Of these women, osteoporosis was only diagnosed after a fracture in almost 60% of the cases. This survey highlights a gap in osteoporosis awareness, as one-fourth of the patients aged 55 years and ov

Rossum raises record $100 million Series A from General Catalyst to reinvent B2B document communication20.10.2021 06:00:00 CEST | Press release

Rossum, the artificial intelligence company that is re-inventing the way businesses send documents to each other, has raised $100m from one of the US’s best known funds, General Catalyst in what is Eastern Europe’s largest ever Series A. Previous investors, including LocalGlobe, Seedcamp, Miton and Elad Gil are participating, as Rossum looks to capitalise on surging corporate demand for automation in business processes. Having rapidly secured market leadership in document AI technology and become the go-to software for many of Europe’s biggest companies, Rossum is creating a universal document gateway designed to help the corporate world move faster and complete transactions in minutes not weeks. Rossum’s founders, three PhD students who dropped out of university to start the business, are automating the whole business communication stack with a view to making bureaucratic, costly and time-consuming document communication frictionless and paperless. Rossum has seen year-on-year growth

Deenova Keeps Trouncing its competitors in France’s Unit Dose Pharmacy Automation Market20.10.2021 06:00:00 CEST | Press release

Deenova announced today it continues its record-breaking market momentum started during Covid-19, by winning 2 mechatronic competitive public tenders this Summer for a total of 4 ACCED robotic medication solutions to be operated around the clock at Centre Hospitalier Sainte-Marie Rodez in Occitanie, and Hospital of St Die-des-Vosges near Strasburg. Loïc Bessin, Managing Director of Deenova in France stated: “When I joined Deenova 3 years ago, the company was a small unit dose specialty business only present in 2 of the Top 5 European markets, having had customers only in France and Italy. I am extremely proud that over the last year alone, we have grown to become the dominant force in the GDP Top 5 healthcare European mechatronics markets for unit-dose, by establishing close partnership with key customers.” Christophe Jaffuel, Deenova Chief Commercial Officer, stated: “After Deenova multi-million and multi-year recent entries into the two largest European GDP healthcare markets in Germ

Amedeo and AURA AERO Announce a Strategic Partnership Agreement and a Letter of Intent to Purchase 200 Electric Regional Aircraft (“ERA”)19.10.2021 19:21:00 CEST | Press release

AURA AERO has created a clean sheet design while integrating new technologies, as well as existing technologies such as fly by wire, and is driving digital efficiencies to build revolutionary momentum in creating an electrical aircraft. With its current prototype aircraft, INTEGRAL, AURA AERO is achieving design and production maturity at a fraction of the cost and will carry that to the commercially sized 19- seater, Electric Regional Aircraft named ‘ERA’. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211019006068/en/ “Amedeo are delighted to have signed an LOI for 200 Electric Regional Aircraft ‘ERA,’ that draws the commercial aviation industry closer to achieving its goal of net-zero by 2050. We are very pleased to be partnered with AURA AERO in leading such an important climate supporting initiative for the future. For Amedeo, sustainable aviation is more than aspirational and we are committed and focused on partnership