Chugai News Releases are issued to provide stakeholders with the most up-to-date information related to our company. In some instances, information on products or drug candidates under development may be included, but this is intended for members of the media, shareholders, and investors. The information is not intended for promotional or advertising purposes, or as medical advice, etc.

Mar 11, 2019

Galderma Presented Results from Phase 2b Study of Nemolizumab in Patients with Atopic Dermatitis at the 2019 AAD Annual Meeting Late-breaking Session

TOKYO, March 11, 2019 –Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Galderma, Nestlé Skin Health’s Medical Solutions Business issued a press release regarding the presentation of the results from phase 2b study of nemolizumab (CIM331) in patients with atopic dermatitis (AD) at the 2019 American Academy of Dermatology Annual Meeting Late-breaking Session held from March 1-5, 2019.

Please refer to the link below for details of the press release issued on March 8, 2019:

  • 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
    https://www.nestleskinhealth.com/news/galderma-presented-final-results-phase-2b-study-nemolizumab-patients-moderate-severe-atopic
    • The study met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared with placebo. A 73% reduction in EASI score was observed at Week 24 with nemolizumab compared with 58% for placebo.
    • Nemolizumab-treated subjects showed early statistically significant improvements in itching and sleep compared with placebo-treated subjects.
    • Nemolizumab was associated with a rapid onset of action on AD symptoms.
    • 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.
    • Galderma is preparing for the global phase 3 pivotal study in mid-2019.

[Note]
Press release issued on July 21, 2016:
Chugai and Galderma Announce Global License Agreement for Nemolizumab (CIM331), Novel Biologic for Skin Diseases
https://www.chugai-pharm.co.jp/english/news/detail/20160721083000_131.html

About EASI
EASI (Eczema Area and Severity Index) is a tool to demonstrate severity of dermatitis with score from 0 to 72.

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