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



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

Norsk Titanium Announces Deployment of RPD Builder™ Tool28.10.2021 18:54:00 CEST | Press release

Norsk Titanium AS (Norsk Titanium; Euronext: NTI), a global leader in Directed Energy Deposition (DED) additive manufacturing of aerospace-grade structural titanium components, announces today a significant advancement to their Rapid Plasma Deposition® (RPD®) process. The company has successfully deployed and validated the internally developed RPD Builder™ computer-aided manufacturing tool for the first time, significantly shortening part development timelines. “This is a tremendous accomplishment for Norsk Titanium,” said Nicholas Mayer, Norsk Titanium’s Vice President of Commercial. “RPD Builder™ is a significant enabler as we move into more industrial manufacturing and engineering services markets. It will give our customers added flexibility and allow them to explore part design options independent from our manufacturing engineering team.” RPD Builder™ has been developed over the past three years and incorporates the full knowledge base of Norsk Titanium’s process metallurgy and ma

FINVASIA Acquires Gini Health, Expands Into Healthcare Services28.10.2021 18:49:00 CEST | Press release

FINVASIA, today, announced its investment in Gini Health, a Canada based healthcare technology company that pioneered DNA and lifestyle data based personalized health to prevent diseases. This acquisition furthers FINVASIA’s strategic business objectives of investing in traditional business and transforming them. The partnership supports FINVASIA’s commitment to health care to accelerate technology-led innovation in preventive and personalized healthcare services. Effective immediately, all the previous investors have exited, making FINVASIA and Gini Health’s founder and CEO Gurjot Narwal key stakeholders in the company. This move by FINVASIA is a step towards making the company’s capital structure lean, providing them more room to support their business strategy. Gini Health’s founder and CEO Gurjot Narwal will keep leading the company. Finvasia along with the investment will provide group resources, operational experience, technology, infrastructure, and its reach as a multidisciplin

Philippine Airlines Boosts Digital Transformation by Switching to Rimini Street Support for its Oracle Footprint28.10.2021 18:00:00 CEST | Press release

Rimini Street, Inc. (NASDAQ: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that Philippine Airlines (PAL), the flagship carrier of the Philippines, has switched to Rimini Street Support for its Oracle E-Business Suite, Fusion Middleware and Database software portfolio. The airline made a strategic decision to move to Rimini Street to help it address the challenges faced by the commercial aviation sector as a result of the global pandemic. By turning over complete support of its Oracle footprint, the airline was able to accelerate key digital innovation projects that support the growth of its business including modernizing its cargo system, integrating its mobile and remote capabilities for more efficiencies and launching its passenger analytics for improving its Know Your Customer program. This press release features multimedia. View the full

Verimatrix Video Protection To Be Deployed Inside New WISI Professional ABR Receiver for Hospitality Networks28.10.2021 17:55:00 CEST | Press release

Regulatory News: Verimatrix, (Euronext Paris: VMX), the leader in powering the modern connected world with people-centered security, and WISI, a world leader in edge video delivery solutions, today announced that Verimatrix video protection technologies are set to be deployed within the new WISI Professional ABR Receiver that enables video operators to connect multiscreen PayTV offerings to the edge while still maintaining existing infrastructure at hospitality sites. Designed to allow video operators that service the world’s major hospitality organizations to avoid costly upgrades, WISI’s Professional ABR (Adaptive Bitrate Streaming) Receiver, along with Verimatrix’s protection technologies, eliminate the need for new set-top boxes or TVs. “By providing operators with a simple path toward migrating to ABR services while still supporting Linear TV deployments at the edge, this WISI-Verimatrix solution stands as a notable example of how close industry collaboration can translate into ma

Ben Cousins Appointed Head of Studio Operations for FunPlus’ European Studios28.10.2021 17:00:00 CEST | Press release

FunPlus, a leading independent mobile game developer and publisher, announced today that Ben Cousins has been appointed Head of Studio Operations, supervising projects in development at FunPlus’ studios in Moscow and Stockholm. Based in Stockholm, and in close collaboration with studio leadership in both locations, Cousins will help to optimize the studios’ working environment and align all studio activities to contribute to successful product development and continued company growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211028005417/en/ Ben Cousins Appointed Head of Studio Operations for FunPlus’ European Studios; Free-to-play and games-as-a-service expert brings more than two decades of experience to the role (Photo: Business Wire) A game industry thought leader, Cousins created Battlefield Heroes, one of the western world’s first free-to-play games. A former Executive Producer of the Battlefield franchise at DIC

Moody’s ESG Solutions’ Climate on Demand tool selected by the Private Infrastructure Development Group28.10.2021 16:02:00 CEST | Press release

Moody’s ESG Solutions announced today that the Private Infrastructure Development Group (PIDG) has selected Moody’s Climate on Demand scoring tool to assess climate risk exposure in its investment projects. PIDG mobilizes private investment in sustainable and inclusive infrastructure in sub-Saharan Africa and south and south-east Asia. It will use Moody’s data to screen potential new investments for exposure to climate hazards based on their precise location, and to assess the physical climate risk exposure of assets in its existing portfolio. PIDG’s investment teams and project sponsors will also leverage the data to inform due diligence and climate risk management and mitigation measures. “We need to ensure that new infrastructure is resilient to the changing climate, especially in the most vulnerable countries,” said Marco Serena, Head of Sustainable Development Impact at PIDG. “Using Moody’s data, we look forward to working with project sponsors and investee companies to understand

Lineage Logistics Launches Nonprofit Lineage Foundation for Good28.10.2021 15:00:00 CEST | Press release

Lineage Logistics, LLC (“Lineage” or the “Company”), the world’s largest and most innovative temperature-controlled industrial REIT and logistics solutions provider, today announced the launch of the Lineage Foundation for Good (the “Foundation”), an independent nonprofit aimed at reducing food waste and fighting food insecurity to support the global communities where over 21,000 of Lineage’s team members live and work. According to the Food and Agriculture Organization of the United Nations (FAO) and the UN Environment Programme (UNEP), an estimated one-third of all food produced globally for human consumption is wasted. Of that number, over 40% is attributed to wasted food in the U.S., which equates to roughly 1.3 billion tons of food and 7% of greenhouse gas emissions. By comparison, 30% of temperature-controlled food products in the U.S. and nearly 10% globally travel through Lineage’s warehouse network. As a result, the Company’s unique visibility into its customers’ inventories a

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