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

Allianz Delivers Record Result and Is Well on Track to Achieve Its Targets7.8.2026 07:10:00 CEST | Press release

2Q 2026 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806509750/en/ Oliver Bäte, Chief Executive Officer of Allianz SETotal business volume at 45.6 billion euros, an internal growth of 5.7 percent1, with contributions from all segments. Asset Management delivers excellent growth. Operating profit rises 10.6 percent to a record level of 4.9 billion euros. Shareholders’ core net income at 2.6 billion euros; 12.7 percent below last year. Adjusted for a divestment gain last year and offsetting measures following the sale of the stake in our Indian JVs, underlying growth is strong at 10 percent. 6M 2026Total business volume at 98.6 billion euros, an internal growth of 4.3 percent1, driven by Property-Casualty and especially Asset Management. Operating profit rises 8.6 percent and reaches a record level of 9.4 billion euros. Shareholders’ core net income advances 15.5 percent to 6.4 billion euros. Adjusted for divestment effec

Pure Lithium Receives Australian Patent for "Lithium Metal Anode and Battery"6.8.2026 22:49:00 CEST | Press release

Pure Lithium Corporation, a vertically integrated next-generation lithium metal battery technology company, today announced that the Australian patent office has granted the company a patent (AU2025271196) titled “Lithium metal anode and battery.” Australia mines roughly half of the world’s lithium, yet has no domestic battery production at all; every battery the country uses is imported. The granted patent is directed to ways in which Pure Lithium’s technology can change that. Rather than trying to catch up in lithium-ion, Australia can leapfrog the incumbent technology and establish a next-generation industry. As worldwide demand for batteries grows, every country capable of making batteries needs to be making them. That is Pure Lithium’s central goal: opening up markets around the world through battery technology that enables local, independent supply chains, keeping pace with demand and strengthening economies. China controls the lithium-ion battery supply chain and manufactures th

Vercel Appoints Amit Agarwal, Standard Template Labs CEO and former Datadog President, to Board of Directors6.8.2026 17:00:00 CEST | Press release

The product leader who helped scale Datadog from early-stage startup through IPO brings deep product expertise to Vercel's board Vercel, the agentic infrastructure company, today announced the appointment of Amit Agarwal, former president of Datadog and founder and CEO of Standard Template Labs, an AI-first service management platform, to its board of directors. Agarwal brings 25 years of enterprise software experience and a track record of scaling a product-led company from its earliest days into one of the defining public software companies of the cloud era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806738617/en/ Amit Agarwal Agarwal joined Datadog in 2012 as its Chief Product Officer and was named President in 2022, overseeing product, corporate development, and go-to-market functions as the company grew past $2.5 billion in annual revenue. Across 13 years, including Datadog's 2019 IPO and its first years as a pub

Laserfiche Launches Advanced Enterprise Security to Deliver Multi-Region Disaster Recovery and GovRAMP-Ready Compliance for Highly Regulated Industries6.8.2026 16:00:00 CEST | Press release

New security suite extends Laserfiche’s proven security controls and adds near real-time data replication for governments, law enforcement and security-conscious enterprises. Laserfiche — the leading SaaS provider of intelligent content management — today announced the launch of Enterprise Security, an advanced suite of security enhancements designed for organizations navigating complex regulatory environments. Enterprise Security addresses GovRAMP and CJIS (Criminal Justice Information Services) security requirements based on the NIST SP 800-53 framework. For organizations handling privileged citizen, legal or corporate data, these built-in controls streamline audit preparation and fortify defenses. With organizations placing a higher priority on data stewardship and corporate governance, enterprise IT leaders require a security architecture that protects data without slowing down operations. Laserfiche Enterprise Security extends Laserfiche Cloud’s highly resilient infrastructure wit

AM Best Upgrades Fortegra Insurance Subsidiaries to A (Excellent)6.8.2026 15:00:00 CEST | Press release

Rating actions follow completion of the DB Insurance acquisition The Fortegra Group, Inc. (“Fortegra” or the “Company”), a global specialty insurer and part of DB Insurance Co., Ltd., today announced that AM Best has upgraded the Financial Strength Rating (FSR) of its insurance subsidiaries to A (Excellent) from A- (Excellent) and the Long-Term Issuer Credit Ratings (Long-Term ICRs) to “a” (Excellent) from “a-” (Excellent). The outlook assigned to the ratings is stable, and AM Best removed the ratings from under review with positive implications. KBRA has also upgraded all of its ratings for the Company. The upgrade applies across Fortegra’s insurance platform. The property and casualty companies include Lyndon Southern Insurance Company, Insurance Company of the South, Response Indemnity Company of California, Blue Ridge Indemnity Company, Fortegra Specialty Insurance Company and Fortegra Europe Insurance Company SE. The life and health companies include Life of the South Insurance Co

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