Galderma Announces Publication of Phase 2b Trial Results Demonstrating the Rapid and Long-lasting Benefits of Nemolizumab in Clinical Trial Subjects With Uncontrolled Atopic Dermatitis
전체 맥락을 이해하기 위해서는 본문 보기를 권장합니다.
"This post-hoc analysis published today in the Journal of the European Academy of Dermatology and Venerology further emphasizes the significant potential of nemolizumab in treating moderate-to-severe atopic dermatitis," said Dr Baldo Scassellati Sforzolini, Global Head of R&D at Galderma. "In our continued commitment to advancing dermatology, these findings demonstrate the multitude of potential benefits that nemolizumab could bring to people living with this severe and chronic disease."
이 뉴스는 기업·기관·단체가 뉴스와이어를 통해 배포한 보도자료입니다.
이 글자크기로 변경됩니다.
(예시) 가장 빠른 뉴스가 있고 다양한 정보, 쌍방향 소통이 숨쉬는 다음뉴스를 만나보세요. 다음뉴스는 국내외 주요이슈와 실시간 속보, 문화생활 및 다양한 분야의 뉴스를 입체적으로 전달하고 있습니다.
LAUSANNE, Switzerland -- Businesswire -- Galderma today announced that the Journal of the European Academy of Dermatology and Venereology (JEADV) has published full results from a post-hoc analysis of the phase 2b study of its investigational therapy, nemolizumab, in adult patients with moderate-to-severe atopic dermatitis (MtS AD).[2] Published online on March 12, results of the analyses show that nemolizumab led to rapid and sustained improvements in itch, sleep, and skin lesions in adult patients with uncontrolled MtS AD.[2]
The published analysis evaluated the efficacy of nemolizumab versus placebo in adult patients with MtS AD:[2]
· Nemolizumab-treated patients experienced significant itch relief within 48 hours of treatment (-22.8% vs -12.3%; p=0.005). This improvement was sustained over the trial, achieving even greater treatment benefit at week 16 (-68.5% vs -30.9%; p<0.001 at week 16). · Rapid improvement of sleep disturbance for patients treated with nemolizumab (30mg) from day three of treatment (-26.6% vs -9.0%; p<0.001) with further improvement by week 16 of treatment (-76.0% vs -36.5%; p<0.001). · Clinically meaningful reductions of 75% EASI were observed at week 16 in 50.0% of nemolizumab patients versus 15.9% of placebo patients (p<0.001) and 90% reductions of EASI were observed for 36.0% of nemolizumab patients and 6.8% of placebo patients (p<0.001). · Nemolizumab was safe and well-tolerated in this population, with nasopharyngitis and upper respiratory tract infection being the most common adverse events observed.
“This post-hoc analysis published today in the Journal of the European Academy of Dermatology and Venerology further emphasizes the significant potential of nemolizumab in treating moderate-to-severe atopic dermatitis,” said Dr Baldo Scassellati Sforzolini, Global Head of R&D at Galderma. “In our continued commitment to advancing dermatology, these findings demonstrate the multitude of potential benefits that nemolizumab could bring to people living with this severe and chronic disease.”
"Atopic dermatitis is a chronic and debilitating disease. We particularly need more treatment options for patients with moderate-to-severe atopic dermatitis. Results from these analyses build on our previous knowledge of nemolizumab’s efficacy in atopic dermatitis and show the potential benefits that it offers for patients with moderate-to-severe atopic dermatitis.”
DR JONATHAN SILVERBERG LEAD AUTHOR, DIRECTOR OF CLINICAL RESEARCH, GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES
Analysis methodology The published post-hoc analysis evaluated the efficacy of nemolizumab versus placebo in adult patients with MtS AD with baseline EASI scores ≥16 (nemolizumab: n=50, placebo: n=44) at week 16. A prior study of nemolizumab has defined MtS AD using an inclusion criteria of EASI ≥12.
About atopic dermatitis Atopic dermatitis is a disruptive and debilitating inflammatory skin disease, characterized by skin lesions and intense itching, which impacts an estimated 1-3% of adults worldwide.[3,4] 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.[5]
About nemolizumab Nemolizumab is a first-in-class humanized monoclonal antibody directed against the IL-31 receptor alpha that blocks signaling from IL-31.[6] IL-31 plays a key role in multiple disease mechanisms in both atopic dermatitis and prurigo nodularis, a rare, potentially debilitating, chronic skin condition with thick skin nodules covering large body areas and associated severe pruritus (itching). With its unique role in directly stimulating sensory neurons related to itch and contributing to inflammation and barrier dysfunction, IL-31 is 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
[1] Atopic Dermatitis. National Eczema Association. Available from: https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/ Accessed: March 2021. [2] Silverberg JI. et al. Nemolizumab is associated with a rapid improvement in atopic dermatitis signs and symptoms: subpopulation (EASI ≥ 16) analysis of randomized phase 2B study. JEADV. 2021. DOI: 10.1111/jdv.17218 [3] Langan S. et al. Atopic dermatitis. The Lancet. 2020;396(10247):345-360. DOI: https://doi.org/10.1016/S0140-6736(20)31286-1 [4] Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl1):8-16. DOI: https://doi.org/10.1159/000370220 [5] Atopic Eczema - Symptoms. NHS. Available from: https://www.nhs.uk/conditions/atopic-eczema/symptoms/ Accessed: March 2021. [6] 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20210408005341/en/
이 뉴스는 기업·기관·단체가 뉴스와이어를 통해 배포한 보도자료입니다.
출처:Galderma
보도자료 통신사 뉴스와이어(www.newswire.co.kr) 배포
Copyright © 뉴스와이어. 무단전재 및 재배포 금지.
- ‘난타’의 송승환 감독, 한국형 에든버러 축제 만든다 - 뉴스와이어
- 기아, 더 뉴 EV6 티저 이미지 공개 - 뉴스와이어
- 이니스프리, 최대 70% 할인 ‘5월 슈퍼 빅세일’ 시작 - 뉴스와이어
- 마이원픽, K-POP SEOUL과 업무 협약 체결… 서울가요대상 월간투표 공동 진행 - 뉴스와이어
- LS일렉트릭, 미래 주도할 친환경 스마트 전력 솔루션 총출동 - 뉴스와이어
- 제14회 화성 뱃놀이 축제 대표 프로그램 ‘바람의 사신단 댄스 퍼포먼스’ 경연대회 시작 - 뉴스
- 삼성전자, 인천공항에서 ‘갤럭시 S24 시리즈’ 무료 대여 서비스 실시 - 뉴스와이어
- 서울대 공대 남기태 교수-김영민 교수 공동 연구팀, 나노입자 입체구조 예측 위한 AI 알고리즘 개
- 김규리 작가 7번째 전시회 ‘Lost Fangs’ 개최 - 뉴스와이어
- 무지방·고단백 설계, 매일유업 ‘매일 바이오 프로틴 요거트’ 출시 - 뉴스와이어