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Content - Chugai drug causes hope for atopic eczema patients

  • April 10, 2017

Chugai drug causes hope for atopic eczema patients

Tokyo (SCCIJ) - Chugai Pharmaceutical, the Japanese subsidiary of Roche Holding from Basel, Switzerland, and the fifth largest pharmaceutical company in Japan, is giving sufferers of atopic dermatitis new hope to reduce their annoying itchiness. During a clinical study conducted by an international group of scientists at seven medical institutions in Japan, the United States and European countries, its self-developed drug "nemolizumab" was found to be effective in suppressing itch. Nemolizumab inhibits the working of interleukin-31, a physiologically active substance causing the itching sensation.

Roche subsidiary Chugai Seiyaku

Antibody blocks itch-causing substance

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

The study was conducted to evaluate the safety and efficacy of nemolizumab in 264 patients with moderate-to-severe atopic dermatitis or eczema, and the safety and efficacy of nemolizumab at twelve weeks were confirmed. The patients were randomized to one of four nemolizumab dose groups and a placebo group. The primary endpoint of the study showed significant reduction of the itching urge compared with the placebo patients. 

Clinical study shows significant improvements

The itching degree lessened by 50 percent or more in about 60 percent of the patients. As a result, they fell asleep faster and their sleep duration grew compared to the placebo group. No major side effects were found, the researchers said. The most common adverse events were the exacerbation of atopic dermatitis, nasopharyngitis, upper respiratory tract infections, peripheral edema, and increased creatine phosphokinase.  

“Control of pruritus is crucial for such patients. It is directly related to their quality of life,” said Yasushi Ito, Senior Vice President, Head of Chugai's Project & Lifecycle Management Unit. “This data emphasizes the importance of controlling interleukin-31 in atopic dermatitis. It also indicates that the antibody nemolizumab may offer a promising treatment option for the disease."  

Anti-itch drug to be marketed by 2019 or 2020

“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 of Ludwig-Maximilian University Munich, the lead author of the study. “Since interleukin-31 is involved in a variety of other pruritic skin diseases, the innovative drug has a large potential in dermatology.”  

“There had been no progress in atopic dermatitis therapies for more than 10 years, and no drugs were available for suppressing itch,” Kenji Kabashima, a professor of dermatology with Kyoto University, and a participating scientist in the international study, told the Asahi Shimbun. “I hope to make sure that patients will have access to the drug two or three years from now.”  

Wide-ranging potential for skin diseases?

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.  

The data from Chugai's global phase II study for the planned indication of atopic dermatitis was published in The New England Journal of Medicine Online on March 2, 2017 under the title “Anti-Interleukin-31 Receptor A Antibody for Atopic Dermatitis.,” Thomas Ruzicka, M.D., et al.    

 

Text: SCCIJ partly with material of Chugai; Photo: Chugai

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