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Chugai's Anti-IL-31 Receptor A Humanized Monoclonal Antibody "nemolizumab (CIM331)" Global Phase II Study Data Published in The New England Journal of Medicine Online

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Chugai
Pharmaceutical Co., Ltd.
(TOKYO:4519) announced today that the data
from the global phase II study (the XCIMA study) for the planned
indication of atopic dermatitis (AD) was published in The New England
Journal of Medicine Online on March 2, 2017 (EST). The study was
conducted to evaluate the safety and efficacy of nemolizumab in 264
patients with moderate-to-severe AD, and the safety and efficacy of
nemolizumab at 12 weeks were confirmed.
"Anti-Interleukin-31
Receptor A Antibody for Atopic Dermatitis.," Thomas Ruzicka, M.D., et al
http://www.nejm.org/doi/full/10.1056/NEJMoa1606490

The efficacy and safety data obtained from a one-year extension of the
study will be presented on March 4th at the Late-Breaking
Research Forums of the
2017 Annual American Academy of Dermatology (AAD) Meeting
which will
be held on March 3 to 7 in Orlando, Florida, USA.

"Control of pruritus is crucial for AD patients. It is directly related
to their quality of life," said Dr. Yasushi Ito, Senior Vice President,
Head of Project & Lifecycle Management Unit. "This data emphasizes the
importance of controlling IL-31 in AD. It also indicates that
nemolizumab, an anti-IL-31 antibody, may offer a promising treatment
option for the disease. Chugai will closely work together with its
partners - Galderma and Maruho, toward helping AD patients by offering
this new treatment option as early as possible."

"Nemolizumab is the first drug specifically targeting pruritus. Its use
is very convenient to patients with one subcutaneous injection per
month," said, Professor Thomas Ruzicka, Ludwig-Maximilian University
Munich, the first author of the article. "Since IL-31 is involved in a
variety of other pruritic skin diseases, the innovative drug has a large
potential in dermatology."

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.
Please refer
to the press release for the details of the license agreement with
Galderma:
https://www.chugai-pharm.co.jp/english/news/detail/20160721083000.html
Maruho:
https://www.chugai-pharm.co.jp/english/news/detail/20160928150000.html

[Overview of the study]
264 patients were randomized to one of the
four nemolizumab dose groups (0.1, 0.5, 2.0 mg/kg every 4 week (Q4W) or
2.0 mg/kg every 8 week) or placebo group (Q4W) in the ratio of
1:1:1:1:1. The primary endpoint of the study showed significant
improvement of the change in pruritus VAS at 12 weeks compared with
placebo with the score of -43.7% for nemolizumab 0.1 mg/kg Q4W, -59.8%
for nemolizumab 0.5 mg/kg Q4W, -63.1% for nemolizumab 2.0 mg/kg Q4W and
-20.9% for placebo Q4W (p<0.01 for all comparisons). The secondary
endpoint was the change in EASI at week 12 of −23.0%, −42.3%, and −40.9%
for the nemolizumab 0.1, 0.5 and 2.0 mg/kg Q4W groups, respectively,
versus −26.6% for placebo. Another secondary endpoint, the proportion
(%) of patients with ≥2-point improvement in sIGA of was 13.8%, 37.5%,
25.1% for the nemolizumab 0.1, 0.5 and 2.0 mg/kg Q4W groups,
respectively, compared with 10.5% for placebo.
The most common
adverse events (AEs) were the exacerbation of AD, nasopharyngitis, upper
respiratory tract infections, peripheral edema, and increased creatine
phosphokinase. 15 patients experienced AEs related discontinuations and
10 out of 15 were due to AEs related to AD (such as exacerbation of AD
and dermatitis exfoliativa).

About nemolizumab (CIM331)
A humanized anti-human IL-31
receptor A (IL-31RA) monoclonal antibody. IL-31 is identified as a
cytokine that can induce pruritus, and reported to be associated with
pruritus in atopic dermatitis and dialysis patients. Nemolizumab works
by inhibiting biological activity of IL-31 through competitively
blocking the binding of IL-31 to its receptor.

About pruritus VAS
Pruritus VAS stands for pruritus visual
analogue scale, by which the severity of pruritus is measured with a 10
cm scale on which patients draw a line to express their assessment of
severity (0: no itch, 10: worst imaginable itch).

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

About sIGA
sIGA (static Investigator's
Global Assessment)
is a tool to evaluate overall severity of dermatitis with a six-level
scale from 0 to 5 (0: clear, 5: very severe).

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