Business Wire

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

Share

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 information

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

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

rf IDEAS ® Adds HID ® Mobile Access to Its WAVE ID ® Mobile Offering6.7.2020 22:57:00 CESTPress release

rf IDEAS, a leading manufacturer of credential readers for logical access and authentication, continues to advance the future of secure mobile access. Developed in partnership with HID Global, the newest addition to the rf IDEAS WAVE ID Mobile reader line supports the HID Mobile Access credential on Bluetooth® Low Energy enabled mobile devices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200706005578/en/ WAVE ID® Mobile for HID® Mobile Access (Graphic: Business Wire) The WAVE ID Mobile for HID Mobile Access provides smartphone users with contactless logical access to workstations, networks, applications, secure printers and more via the HID credential. This new reader also provides support for nearly any physical proximity or contactless smart card in use worldwide. The HID Mobile Access credential can be obtained from HID Global through rf IDEAS. It is based on the highly secure SEOS® platform and delivered through an ea

New UC Berkeley Global Program for Freshmen Offers an Online “Study-Abroad” Option6.7.2020 19:40:00 CESTPress release

UC Berkeley Global is proud to announce its Global Program for Freshmen (GPF), launching Fall 2020. This unique “online study-abroad” program is designed for incoming first-year university students seeking a close-knit, collaborative learning community within a digital-learning environment. Students will have access to Berkeley instructors and mentors while working closely with their peers in small cohorts using online tools. GPF offers courses in Letters & Science (L&S) that cover key prerequisites for majors across various disciplines. Elective courses allow students to complete a total of 15 credits per semester, while additional programming will focus on important issues for first-year students, including preparing for college life, selecting a major and career development. Upon completion, students earn credits that they can transfer to their home institution. This makes GPF an ideal opportunity for universities seeking a high-quality online option for their incoming students, or

Research Enhances Understanding of the Nutritional and Economic Differences in Soybean Meal from Different Origins6.7.2020 16:17:00 CESTPress release

A new meta-analytical study reinforces U.S. Soy’s reputation for being a global leader in quality and nutrient-density. The study, entitled, “Chemical composition, protein quality and nutritive value of commercial soybean meals produced from beans from different countries,” demonstrates that not all soybean meals are created equal and that meal from different countries of origin should be treated individually when formulating swine and poultry diets. The data from this study were then processed by the Nutrient Value Calculator (NVC), a software tool constructed by Genesis Feed Technologies, a company built to bring visibility into feed costs. This cost analysis supported the economic benefits of U.S. soybean meal relative to meal from other origins as a key ingredient in poultry rations. Dr. Gonzalo Mateos, Professor of Animal Science at the University of Madrid in Spain and study co-author, first presented findings from the meta-analysis at the U.S. Soybean Export Council’s (USSEC) As

Echosens Announces NICE, UK Health Technology Assessment Organization, Issues MedTech Innovation Briefing on FibroScan Liver Exam in Primary Care6.7.2020 15:00:00 CESTPress release

Echosens, a high-technology company offering the FibroScan family of products, announces today that the National Institute for Health and Care Excellence (NICE), the United Kingdom’s health technology assessment body providing national guidance and advice to improve health and social care, issued a MedTech Innovation Briefing (MIB) dedicated to utilization of FibroScan non-invasive technology in the primary care setting. The NICE experts concurred that this approach could provide a cost-effective way for the National Health System (NHS) to assess liver fibrosis and cirrhosis in primary care--reducing the need for treatment, referrals and biopsies, and improving accuracy and speed. “Using FibroScan as an interventional therapy helps primary care physicians and nurse specialists engage patients by demonstrating the results and outcomes as a value change that patients can visualize on a regular basis and give them confidence that their efforts have an impact,” says Louise Campbell, patien

WEP Clinical Partners With Nabriva Therapeutics for the Named Patient Supply of XENLETA ® (lefamulin)6.7.2020 13:00:00 CESTPress release

WEP Clinical (WEP), a specialist pharmaceutical services company, has signed an exclusive agreement with Nabriva Therapeutics (Nabriva) to supply XENLETA® (lefamulin) on a named patient or expanded access basis. The Named Patient Program (NPP) is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available. XENLETA was discovered and developed by Nabriva (NASDAQ: NBRV), a commercial-stage biopharmaceutical company focused on commercialization and development of anti-infective agents. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. XENLETA is the first and only oral and IV pleuromutilin empiric antibiotic that acts against the pathogens that commonly cause CABP. Nabriva announced on May 29th

Pudu Robotics Raised over $15M Series B Financing with Meituan as the Exclusive Investor6.7.2020 11:11:00 CESTPress release

On July 1, 2020, Pudu Robotics, an indoor delivery robot provider, officially announced the completion of B round financing of more than $15M with Meituan as the exclusive investor. Zhang Tao, CEO of Pudu Robotics, said the fund would be mainly used to develop products, expand sales, explore new usage scenarios and expand overseas market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200706005180/en/ (Photo: Business Wire) Pudu Robotics is a top-notch intelligent indoor delivery robot provider in China. The company focuses on the R&D, design and production of robots and offers a number of popular delivery robots, including PuduBot (food delivery robot), BellaBot (food delivery robot), HoloBot (building delivery robot), HolaBot (dish-return robot), and GazeBot (multi-scene delivery robot). Its first mass-produced robot PuduBot has been widely used in extensive scenarios, including restaurants, hotels, office buildings, hospi