Business Wire

GALDERMA

8.3.2019 15:02:05 CET | Business Wire | Press release

Share
Galderma Presented Final Results from Phase 2b Study of Nemolizumab in Patients with Moderate-to-Severe Atopic Dermatitis at the 2019 American Academy of Dermatology Annual Meeting Late-Breaking Session

Galderma, Nestlé Skin Health’s medical solutions business, presented the final results from a Phase 2b dose-ranging study of nemolizumab, an investigational therapy in adult patients with moderate-to-severe atopic dermatitis (AD), at the late-breaking session of the 2019 American Academy of Dermatology annual meeting (March 1-5).

Nemolizumab is a first-in-class investigational monoclonal antibody that blocks signaling of IL-31, a cytokine that plays a key role in the pathogenesis of moderate-to-severe AD.

Moderate to severe AD is a serious, chronic form of eczema associated with a high burden of disease linked to itch, sleep deprivation and significant quality of life impairment. This double blind, placebo-controlled, 24 week, dose-ranging Phase 2b study enrolled 226 subjects with moderate-to-severe AD not adequately controlled with topical corticosteroids. All groups received concomitant topical corticotherapy.

This study met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared with placebo. A 73 percent reduction in mean EASI score was observed at Week 24 with nemolizumab compared with 58 percent for placebo.

Nemolizumab was well-tolerated across all dose levels in this trial. The most common adverse events observed were nasopharyngitis and upper respiratory tract infection. Subjects with pre-existing asthma reported an increase in asthma related events; these events were mostly mild and were reversible under treatment.

Nemolizumab-treated subjects showed statistically significant improvements in key secondary efficacy measures compared with placebo after 16 weeks of treatment:

  • 33 percent of nemolizumab-treated subjects achieved clear or almost-clear skin as measured by an investigator’s global assessment (IGA) score of 0 or 1, compared with 12 percent of placebo-treated subjects (p=0.008);
  • 49 percent of nemolizumab-treated subjects achieved 75 percent reduction in EASI score compared with 19 percent of placebo-treated subjects (p<0.01); and
  • 68 percent of nemolizumab-treated subjects achieved at least 4-point reduction in itch, as measured by the pruritus numerical-rating scale (NRS) score, compared with 21 percent reduction in placebo-treated subjects. (p<0.001).

In addition, nemolizumab was associated with a rapid onset of action on AD symptoms: nemolizumab-treated subjects showed early statistically significant improvements in itching and sleep compared with placebo-treated subjects as measured by pruritus NRS and sleep disturbance NRS.

“We are excited by this Phase 2b late-breaking presentation and to be able to report that nemolizumab met all study endpoints in treatment of moderate to severe atopic dermatitis. These new data have added to growing evidence generated with our partner, Chugai, highlighting the importance of the IL-31 pathway as a key driver in moderate to severe atopic dermatitis,” said Thibaud Portal, Ph. D., Global Vice President of Galderma’s Prescription Business.

“The results of this Phase 2b study showed that nemolizumab significantly improved atopic dermatitis signs and very rapidly improved atopic dermatitis symptoms, including pruritus and sleep disturbance. These findings show why nemolizumab is such a promising new investigational drug and how it could be helpful in treating moderate to severe atopic dermatitis,” said Dr. Jonathan I Silverberg, Principal Investigator of the Phase 2b program, from the Department of Dermatology, North Western University, Chicago, IL, USA.

Galderma is now actively preparing for a worldwide Phase 3 pivotal program which will be implemented by mid-2019.

About the IL-31 Pathway and Atopic Dermatitis
Moderate-to-severe atopic dermatitis (AD), a serious, chronic form of eczema, is a systemic inflammatory disease characterized by an allergic response driven by a subset of immune cells called Type 2 helper T cells, or Th2 cells. IL-31, a cytokine released by Th2 cells, is involved in AD associated pruritus by interacting with IL-31 receptor alpha expressed by neuron. IL-31 is also thought to play a role in AD skin inflammation and AD skin barrier impairment. Moderate-to-severe forms of AD can be characterized by pronounced cutaneous dryness, and skin lesions marked by redness, infiltration/papulation, crusting/oozing, and lichenification, with periods of lesion exacerbation accompanied by intense itching, scratching, and skin damage that can lead to secondary infections. Moderate-to-severe AD can negatively impact patients’ lives and is associated with a high burden to patients particularly with itching, sleep deprivation and depression.

About Nemolizumab
Nemolizumab, a first-in-class humanized monoclonal antibody, is directed against the IL-31R alpha, which blocks signaling from both IL-31. Nemolizumab, initially developed by Chugai, was subsequently licensed to Nestlé Skin Health in 2016. 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, Nestlé Skin Health’s medical solutions business, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. 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

Contact:

Media : Sébastien Cros, Head of Corporate Communications info@nestleskinhealth.com

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

MTN Group Fintech Advances Digital Transformation Through Strategic Technology Partnership11.6.2026 04:00:00 CEST | Press release

MTN Group Fintech has entered into a strategic partnership with Ant International, a leading global digital payment, digitisation and financial technology provider, to accelerate the transformation of its mobile money ecosystem. The partnership, which is expected to launch in Nigeria next quarter, will introduce a super-app platform designed to enhance user experience, deepen digital inclusion and enable a next-generation ecosystem for digital finance, lifestyle and commerce services around MoMo. By leveraging Ant International’s advanced technology, MTN is evolving MoMo to enable stronger ecosystem integration through a mini app platform, enhanced fraud prevention and richer engagement features for consumers and merchants. The partnership represents a major step in building a more resilient and future-ready digital ecosystem. “This partnership aligns with MTN Group’s ambition of leading digital solutions for Africa’s progress by leveraging scale, technology and strong global partnersh

Andersen Global styrker sine globale mobilitetskompetencer med tilføjelsen af Courdid BV10.6.2026 22:05:00 CEST | Pressemeddelelse

Andersen Global har indgået en samarbejdsaftale med Courdid BV, som er et hollandsk konsulentfirma inden for global mobilitet, hvilket yderligere styrker organisationens rådgivningskapacitet for internationale arbejdsstyrker og expats. Courdid BV blev grundlagt for næsten to årtier siden og tilbyder en bred vifte af rådgivningstjenester inden for lønsums- og lønskat, expatbeskatning, lønudbetaling, immigration samt employer of record-løsninger. Virksomheden samarbejder med multinationale arbejdsgivere, offentlige institutioner og professionelle serviceudbydere om at levere praktisk og skræddersyet rådgivning om komplekse internationale arbejdsstyrkeforhold – kendetegnet ved en kundeorienteret tilgang, der prioriterer tilgængelighed og personlig service. "Vi bestræber os på at være praktiske og relevante for vores klienter, særligt inden for områder, der ofte er unødigt komplekse," siger Jean-Paul van ’t Hof, der er administrerende partner i Courdid BV. "Ved at blive en samarbejdende vi

TestMu AI Announces Day-Zero Support for macOS Golden Gate and iOS 27 Beta Following WWDC 202610.6.2026 21:52:00 CEST | Press release

Developers can now test websites, web applications, and mobile apps on Apple's latest operating systems before their public release TestMu AI (formerly LambdaTest), the world's first full-stack Agentic AI Quality Engineering platform, today announced day-zero support for Apple's newly unveiled operating systems, macOS Golden Gate and iOS 27 Beta, across its cloud testing platform. Announced at Apple's Worldwide Developers Conference (WWDC) 2026, macOS Golden Gate and iOS 27 introduce significant platform updates that will impact application compatibility, user experience, and performance. Both operating systems are now available for testing on TestMu AI, the same day Apple released its beta versions, allowing engineering teams to identify issues months before the stable rollout reaches millions of users worldwide. macOS Golden Gate is available through the TestMu AI Real Time Testing platform, while iOS 27 Beta is available on TestMu AI Real Device Cloud across the latest iPhones and i

Pure Lithium Corporation Named World Economic Forum Technology Pioneer10.6.2026 20:10:00 CEST | Press release

Lithium metal battery innovator joins a select global cohort of 100 pioneering companies shaping the future of energy and advanced materials Pure Lithium Corporation, a disruptive lithium metal battery technology company, is pleased to announce that the company has been selected as a 2026 Technology Pioneer by the World Economic Forum. Launched in 2000, the Technology Pioneers is a leading community for companies from around the world that are shaping the future through breakthrough technologies and innovations. These companies are selected for their potential to have a significant impact on business and society and are invited to engage with public and private sector leaders through the World Economic Forum’s global platform. “We are delighted to be selected as a World Economic Forum Technology Pioneer. I would like to express my gratitude to the World Economic Forum for this honor,” said Pure Lithium Founder, Chairman and CEO, Emilie Bodoin. “Pure Lithium’s selection is a testament t

Visa Partners with OpenAI to Power the Next Generation of AI Commerce10.6.2026 20:00:00 CEST | Press release

New collaboration brings Visa’s global payment networkto one of the largest AI platforms and aims to support seamless, secure transactions and broader AI-powered use cases across commerce environments supported by agents Visa (NYSE: V) today announced a strategic collaboration with OpenAI to enable secure Visa payments within agentic commerce, enabling seamless and trusted payments across OpenAI. The companies made the announcement at the Visa Payments Forum in San Francisco. Through the partnership, Visa will provide its global network, credentialing capabilities and security infrastructure to support agentic commerce experiences, helping consumers and businesses interact and transact with confidence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610422687/en/ The collaboration is part of the broader Visa Intelligent Commerce initiative, which is focused on extending secure payment capabilities into new digital environm

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye