Chugai's Anti-IL-31 Receptor A Humanized Monoclonal Antibody "nemolizumab," Long Term Data from Global Phase II Study Publish...
May 10 2018 - 2:00AM
Business Wire
-- Confirmed Safety and Efficacy of nemolizumab
for One Year Treatment --
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today
that the long-term data from a global phase II study (the XCIMA
study) for nemolizumab (CIM331) was published in Journal of Allergy
and Clinical Immunology Online on May 9, 2018.“Nemolizumab in
moderate-to-severe atopic dermatitis: Randomized, phase II,
long-term extension study” Kenji Kabashima, M.D., Ph.D., et
alhttps://www.jacionline.org/article/S0091-6749(18)30698-5/abstract
“Control of chronic pruritus and inflammation of the skin is
crucial for patients with atopic dermatitis (AD). This long-term
extension data which demonstrated efficacy and safety of
nemolizumab reinforced anticipation that nemolizumab may offer a
novel treatment option for the disease,” said Dr. Yasushi Ito,
Executive Vice President, Co-Head of Project & Lifecycle
Management Unit. “Chugai’s mission is to contribute to patients
through innovative medicines. We will closely work together with
our partners - Galderma and Maruho, towards helping AD patients by
developing this new treatment option as quickly as possible.”
“I am delighted to see a steady development of the novel
treatment which addresses pathogenesis of pruritus in atopic
dermatitis,” said, Professor Kenji Kabashima, Kyoto University, the
first author of the article. “I would like to carefully examine
safety and efficacy of nemolizumab further, in the expectation of
future clinical use.”
The study was conducted to evaluate safety and efficacy of
nemolizumab in 264 patients with moderate-to-severe AD. The safety
and efficacy of nemolizumab at 12 weeks, the study’s primary
endpoint, were confirmed and published in The New England Journal
of Medicine Online in March 2017. The data published this time was
obtained to assess safety and efficacy of long-term administration.
It confirmed that nemolizumab maintained its safety and efficacy
after one year of continuous treatment.
About the results of the global phase II study
Press release issued in March 2,
2017.https://www.chugai-pharm.co.jp/english/news/detail/20170302150000.html
Chugai granted the exclusive development and marketing rights of
nemolizumab worldwide, excluding Japan and Taiwan, to Galderma and
licensed out the development and marketing rights in the skin
disease area to Maruho for the Japanese market respectively.
Currently, Galderma is conducting a phase 2b study and Maruho is
conducting a phase 3 study.
Please refer to the press release for the details of the license
agreement withGalderma:
https://www.chugai-pharm.co.jp/english/news/detail/20160721083000.htmlMaruho:
https://www.chugai-pharm.co.jp/english/news/detail/20160928150000.html
About nemolizumab (CIM331)
Nemolizumab (CIM331) is a humanized anti-human IL-31 receptor A
(IL-31RA) monoclonal antibody intending to be a first-in-class
treatment. IL-31 is identified as a pro-inflammatory cytokine that
can induce pruritus, inflammation, and skin barrier dysfunction in
atopic dermatitis, as well as pruritus in dialysis patients1, 2, 3,
4). Nemolizumab is thought to work by inhibiting biological
activity of IL-31 through competitively blocking the binding of
IL-31 to its receptor.
Trademarks used or mentioned in this release are protected by
law.
[References]1. Sonkoly E, et al., IL-31: A new link between T
cells and pruritus in atopic skin inflammation. J Allergy Clin
Immunol 2006; 117: 411-7.2. Cornelissen C, et al., IL-31 regulates
differentiation and filaggrin expression in human organotypic skin
models. J Allergy Clinical Immunol 2012; 129: 426-33.3. Kasraie S,
et al., Interleukin (IL)-31 induces pro-inflammatory cytokines in
human monocytes and macrophages following stimulation with
staphylococcal exotoxins. Allergy 2010; 65: 712-21.4. Ko MJ, et
al., Interleukin-31 is associated with uremic pruritus in patients
receiving hemodialysis. J Am Acad Dermatol 2014; 71: 1151-9.
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