TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced that the results
of global phase II study of anti-IL-31 receptor A, humanized monoclonal
antibody, nemolizumab (CIM331), which is currently developed for atopic
dermatitis, were released at the annual meeting of the American Academy
of Dermatology currently held in Washington, D.C.
The results were
released at the Late-breaking Research Forums at 10:00 on Saturday,
March 5 (local time).
The global phase II study was conducted to evaluate the efficacy and safety of CIM331 in 264 patients with moderate to severe atopic dermatitis. Efficacy and tolerability for 12 weeks treatment were observed in this study.
“Itch in atopic dermatitis disturbs sleep and quality of life of those who suffer from the disease. Moreover, the itch-scratch cycle may aggravate symptoms of dermatitis. CIM331 is a drug candidate with a novel mechanism of action, which improves dermatitis by blocking the itch-scratch cycle,” said Chugai’s Director and Executive Vice President, Dr. Yutaka Tanaka. “We are delighted that the efficacy and safety results in this study have demonstrated the possibility of CIM331 to provide a new treatment concept for patients around the world.”
[Study overview]
Patients were randomized to one of the following
four CIM331 dose groups or placebo group in the ratio of 1:1:1:1:1.
- CIM331 (0.1 mg/kg) subcutaneous dosing every 4 weeks (Day 1, Week 4, and Week 8)
- CIM331 (0.5 mg/kg) subcutaneous dosing every 4 weeks (Day 1, Week 4, and Week 8)
- CIM331 (2.0 mg/kg) subcutaneous dosing every 4 weeks (Day 1, Week 4, and Week 8)
- CIM331 (2.0 mg/kg) subcutaneous dosing every 8 weeks (reference group)
- Placebo subcutaneous dosing every 4 weeks (Day 1, Week 4, and Week 8)
[Study results]
Efficacy
- The percent change in pruritus VAS at Week 12, which was the primary endpoint, was significantly higher in the CIM331 treatment groups than in the placebo group (p<0.01 in all).
|
Placebo |
0.1 mg/kg every 4 weeks |
0.5 mg/kg every 4 weeks |
2.0 mg/kg every 4 weeks |
|||||
|
Percent change in |
-20.1 | -41.5 | -61.2 | -60.5 | ||||
- In addition, dermatitis endpoints (i.e. EASI and sIGA) and sleep quality endpoints (i.e. sleep onset latency and total sleep time) were presented.
Safety
- Tolerability was observed in CIM331 treatment groups. Adverse events reported relatively frequently were atopic dermatitis and nasopharyngitis.
About Late-breaking Research Forums
This session will
highlight the latest ground-breaking clinical and basic research
performed. New therapies will be given top priority, particularly data
from pivotal trails of unapproved drugs or unapproved indications. In
addition, novel observations that could be practice changing will also
be given top consideration.
About nemolizumab (CIM331)
It is a humanized
anti-human-IL-31-receptor-A (IL-31RA) monoclonal antibody. IL-31 is
identified as a cytokine that can induce the 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).
About Itch-scratch cycle
Skin itchiness causes scratch,
which enhances inflammation and further aggregation of itchiness. This
vicious cycle called the itch-scratch cycle is known as an exacerbating
factor for dermatitis.
About Chugai
Chugai Pharmaceutical is one of Japan’s leading
research-based pharmaceutical companies with strengths in biotechnology
products. Chugai, based in Tokyo, specializes in prescription
pharmaceuticals and is listed on the 1st section of the Tokyo Stock
Exchange. As an important member of the Roche Group, Chugai is actively
involved in R&D activities in Japan and abroad. Specifically, Chugai is
working to develop innovative products which may satisfy unmet medical
needs, mainly focusing on the oncology area.
In Japan, Chugai’s
research facilities in Gotemba and Kamakura are collaborating to develop
new pharmaceuticals, and laboratories in Ukima are conducting research
for technology development for industrial production. Overseas, Chugai
Pharmabody Research based in Singapore is engaged in research focusing
on the generation of novel antibody drugs by utilizing Chugai’s
proprietary innovative antibody engineering technologies. Chugai Pharma
USA and Chugai Pharma Europe are engaged in clinical development
activities in the United States and Europe.
The consolidated
revenue in 2015 of Chugai totalled 498.8 billion yen and the operating
income was 90.7 billion yen (IFRS Core basis).
Additional
information is available on the internet at http://www.chugai-pharm.co.jp/english.
