October 31, 2013
Results of a Phase 2 Study of KHK4827 in Subjects with Psoriasis in Japan
Tokyo, Japan, October 31, 2013 -- Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced today that KHK4827 (Generic name: brodalumab) achieved the primary efficacy endpoint in a phase 2 study to treat subjects with plaque psoriasis in Japan.
It was a double-blind, placebo-controlled study in subjects with moderate to severe plaque psoriasis to investigate the efficacy and safety of KHK4827. Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) 12 weeks after the start of subcutaneous treatment with KHK4827 at 70, 140 and 210 mg, which was the primary endpoint of the study, presented a significant elevation compared with the placebo group. No clinically significant safety issues were identified.
The development of KHK4827 will be continued based on these results.
KHK4827, created by Amgen Inc. (Thousand Oaks, California; CEO: Robert A. Bradway), is a fully human anti-interleukin-17 receptor antibody. It is a lead product candidate licensed from Kirin-Amgen, Inc. pursuant to the agreement concluded on October 29, 2010 for exclusive rights in Japan and other Asian countries to develop and commercialize.
Kyowa Hakko Kirin develops innovative new drugs focusing on the areas of oncology, nephrology and immunology/allergy. Kyowa Hakko Kirin continues to expand the frontiers of pharmaceutical development with antibody technology backed by cutting-edge biotechnology to pursue the health and well-being of people worldwide.
Psoriasis is a chronic skin disorder. Typical symptoms include systemic erythema with clearly demarcated lesions, induration and hyperplasia inducing silver white plaques on skin. About 50% of the patients experience itching. Inflammatory arthritis and abnormality in nail morphology may also manifest.
PASI is a tool to assess the severity of symptoms resulting from psoriasis by scores. The body is divided into 4 sections comprising the head, trunk, upper limbs, and lower limbs. For each section, severity of clinical signs (erythema, induration, desquamation plaque) and percentage of area of skin affected are scored.
About Amgen, Inc.
Amgen Inc. is an international, leading biotechnology company originally founded in 1980. With approximately 20,000 employees, the company discovers, develops and markets novel and innovative human therapeutics. For further information, please visit "http://www.amgen.com".
Interleukin-17 is a protein produced in the body, mostly in the activated T lymphocytes. Overexpression of interleukin-17 turns on the immune system to attack itself, though the system is originally supposed to work for host-defense by removing foreign pathogens. The reaction is assumed to be involved in autoimmune disease such as psoriasis. Blocking the functions of interleukin-17 may lead to slow the progression of symptoms or to be a therapeutic intervention for such diseases.
About Kirin-Amgen, Inc.
A joint-venture between Kirin Holdings and Amgen.
Kyowa Hakko Kirin