Business Wire

Chugai Announces Phase II Global Study Results of Nemolizumab (CIM331) in Late-breaking Research Forums at AAD


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]

  • 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).

every 4 weeks

  0.1 mg/kg
every 4 weeks
  0.5 mg/kg
every 4 weeks
  2.0 mg/kg
every 4 weeks

Percent change in
pruritus VAS
(At Week 12; %)

  -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.


  • 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

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Koki Harada
Tel: +81-3-3273-0881
For US media
Chugai Pharma USA, Inc.
Casey Astringer
Tel: +1-908-516-1350
For European media
Chugai Pharma France SAS
Nathalie Leroy
Tel: +33-1-56-37-05-21
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Susan Chou, Osamu Kagawa
Tel: +886-2-2715-2000
For Investors
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
Toshiya Sasai
Tel: +81-3-3273-0554

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Digi Communications N.V.: Convocation of the Company’s General Shareholders Meeting for 2 May 2018 for the Approval of, among Others, the 2017 Annual Report and of the 2017 Financial Statements21.3.2018 19:05Pressemelding

The Company would like to inform the market and its investors that today, 21 March 2018, the Board of Directors of the Company convenes the general shareholders meeting of the shareholders (the “GSM”) of the Company (Digi Communications N.V.), to be held on Wednesday, 2 May 2018 at 12:00 p.m. CEST, at Radisson Blu Hotel Amsterdam airport, Boeing avenue 2, 1119 PB Schiphol-Rrijk, The Netherlands. The main topics for the GSM are the following: discussion and approval items on the Annual Report 2017 (including the annual report, the financial statements (consolidated and stand-alone) and the auditor report); appointment of the statutory auditor for the year ending 31 December 2018; approval for the distribution of a gross dividend of 0.35 RON per share; ex-date – 21 May 2018, reference date – 22 May 2018, and the payment date – 29 May 2018; designation of the Board of Directors as the competent body to repurchase own Class B Shares; approval of award of stock options and shares to executi

Pandora to Acquire Leading Digital Audio Ad Tech Firm AdsWizz21.3.2018 13:00Pressemelding

Pandora (NYSE: P), the largest music streaming service in the U.S., today announced it will acquire AdsWizz, the global leader in digital audio ad technology. The addition of AdsWizz will upgrade Pandora’s ad tech capabilities, provide its advertisers with greater audience reach, and expand the company’s revenue opportunities. AdsWizz is one of the few ad tech firms that is completely dedicated to digital audio, serving some of the largest players in the industry. With digital audio advertising growing 42% year-over-year, according to the IAB, the combined offering of Pandora and AdsWizz will capitalize on this trend, while making it easier for publishers to monetize their inventory, and for advertisers to buy and measure their campaigns. “Since I joined Pandora six months ago, I have highlighted ad tech as a key area of investment for us. Today we took an important step to advance that priority and accelerate our product roadmap,” said Roger Lynch, CEO of Pandora. “With our scale in a

Fintech Entrepreneur and myPOS Founder Christo Georgiev Reveals Plans to Set Up a Chain of myPOS Stores across Europe21.3.2018 12:51Pressemelding

Founder of myPOS, Christo Georgiev announces plans to open myPOS flagship stores across Europe in an effort to bring the service closer to its customers. Designed for small and mid-sized businesses, myPOS offers affordable payment acceptance tools, winning the trust of over 40,000 enterprises across the EEA & Switzerland. This press release features multimedia. View the full release here: An interior view of the myPOS London Store (Photo: Business Wire) Until now, the operational framework of myPOS included a network of promoters in almost every European country and an online store, owned and operated by myPOS. The next logical step was to sell through physical stores. On 8th February 2018, myPOS opened doors to its first flagship store, located on 36 Knightsbridge, London and marked the beginning of a new era for myPOS. Soon after, plans were revealed for other openings in Europe with another location coming up on 5th April 201

AI Expo Europe: The leading Artificial Intelligence Event to Arrive in the European Capital of Innovation, Amsterdam21.3.2018 12:47Pressemelding

The AI Expo Europe is set to arrive in the hub of AI innovation, Amsterdam, The Netherlands, this Summer (27-28th June) with an aim of ‘delivering AI for a smarter future.’ The well-connected Dutch capital is known for its unique, rich culture and canal-side views and was even awarded the European Capital of Innovation in 2016 by the European Commission. The city’s AI scene is thriving with the arrival of a world-class artificial intelligence hub by early 2021 and venture capitalist investment. The AI hub will be created in collaboration with the University of Amsterdam (UvA) and the City of Amsterdam at the Amsterdam Science Park, a place where education, research and entrepreneurship will come together as one. Geert ten Dam, president of the UvA’s Executive Board stated that: “Amsterdam is widely recognised both in the Netherlands and abroad for its leading scientific expertise in the area of AI…” This press release features multimedia. View the full release here: https://www.busines

Philip Morris International Shifts Entire Capacity of Its Cigarette Factory in Greece to Smoke-Free Products21.3.2018 12:31Pressemelding

Philip Morris International Inc. (PMI) (NYSE: PM) announced today that the factory of its Greek affiliate (Papastratos) in Aspropyrgos, has ceased cigarette production and is now exclusively producing HEETS, the tobacco units used with IQOS, the company’s most advanced smoke-free product. This first full conversion of a cigarette factory is a landmark step in our vision of a smoke-free future where people who smoke switch from the most harmful form of nicotine consumption – cigarettes – to scientifically substantiated smoke-free alternatives. The EUR 300 million investment included the construction of three new buildings and the replacement of cigarette production lines with high-tech facilities capable of producing 10,000 smoke-free tobacco units per minute. The conversion of the factory started in August 2017. The facility is expected to be fully operational by the end of 2018 and will create 400 new jobs. André Calantzopoulos, PMI’s Chief Executive Officer said: “This is a historic

GSMA Advances a Comprehensive Agenda on Digital Inclusion for Women Ahead of G20 Summit21.3.2018 12:00Pressemelding

The GSMA is supporting the sixty-second meeting of the Commission on the Status of Women (CSW62) taking place at the United Nations Headquarters in New York this month1 as part of its commitment to the Sustainable Developments Goals (SDGs), particularly SDG 5 (Gender Equality). The GSMA’s role at the event reflects its status as Topic Chair of the Digital Inclusion theme within the W20 (Women 20) group2, which will advise the G20 member states on issues around gender equality and the economic empowerment of women. At CSW62, the GSMA and its partners will be convening parallel events across a range of topics in this area, bringing together companies in the mobile ecosystem, governments, UN agencies and NGOs. “Developing forward-looking policies that promote digital inclusion for women is vital to achieving gender equality, serving to empower women in all corners of the world as well as providing an effective catalyst for economic growth,” said Mats Granryd, Director General of the GSMA.