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March 5, 2015

Kyowa Hakko Kirin Announces Commencement of Phase 2 Clinical Study of RTA 402 in CKD patients with type 2 diabetes in Japan

Tokyo, Japan, March 5, 2015 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced today that the initiation of phase 2 clinical study in Japan for bardoxolone methyl (RTA 402), a small-molecule compound licensed from Reata Pharmaceuticals, Inc. (Irving, Texas, USA; CEO and President: Warren Huff; "Reata").

This randomized, placebo-controlled, double-blind study is designed to assess efficacy and safety of RTA 402 in CKD patients with type 2 diabetes. RTA 402 is administered once daily for 16 weeks in an intrapatient dose escalation design.

Kyowa Hakko Kirin signed a license agreement with Reata for the exclusive rights to develop and commercialize bardoxolone methyl in Japan, China, Taiwan, Korea, and Southeast Asia on December 24, 2009. Reata is presently conducting a Phase 2 clinical study of bardoxolone methyl for treatment of pulmonary arterial hypertension in the US (LARIAT; New window opensNCT02036970).

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

Outline of this study Identifier New window opensNCT02316821
Target Population CKD patients with type 2 diabetes
Trial Design Randomized, placebo-controlled, double-blind study
Administration Group RTA 402, Placebo
Target Number of Subjects 72
Primary Objective Safety
Efficacy (Changes in GFR from baseline to week 16)
Trial Location Japan
Trial Duration Dec. 2014 to Dec. 2017

About Bardoxolone methyl
Bardoxolone methyl activates Nrf2, which controls the production of over 250 antioxidant and detoxification proteins. Activation of Nrf2 protects tissues from inflammation by increasing cellular antioxidant content and suppressing inflammatory signaling pathways. Chronic inflammation has been shown to promote type 2 diabetes and its complications, including cardiovascular events and CKD.

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