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July 2, 2014

Future Development Direction for Bardoxolone Methyl (RTA 402)

Tokyo, Japan, July 2, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced today that the company has decided the future development direction in Japan for bardoxolone methyl*1 (RTA 402), a small-molecule compound licensed from Reata Pharmaceuticals, Inc. (Irving, Texas, USA; CEO and President: Warren Huff; "Reata"). Under the new direction, Kyowa Hakko Kirin will start a new Phase 2 clinical study on bardoxolone methyl.

An increased risk was observed in the Phase 3 placebo-controlled comparative clinical study in chronic kidney disease (CKD) patients with type 2 diabetes conducted by Reata in the US, Europe, Canada, Australia, and Central America (the BEACON study), particularly heart failure, in patients in the bardoxolone methyl arm of the study. Therefore, in November 2013 Kyowa Hakko Kirin decided to discontinue a suspended Phase 2 clinical study and to investigate a future development strategy for bardoxolone methyl.

Kyowa Hakko Kirin has since decided to continue developing this compound for CKD patients with type 2 diabetes with a particular emphasis on patient safety, following a detailed analysis*2 of the BEACON study data and consultations with the Pharmaceuticals and Medical Devices Agency (PMDA). The company plans to evaluate both the safety and efficacy of bardoxolone methyl in a new Phase 2 clinical study to be performed in Japan.

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 continuing the clinical development of bardoxolone methyl in other territories, and is presently conducting a Phase 2 study of bardoxolone methyl in pulmonary arterial hypertension (LARIAT; NCT 02036970).

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.

This decision will have a minimal effect on the performance of Kyowa Hakko Kirin.

*1: 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.

*2: Analysis of the BEACON study data
The results from this analysis were presented at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress held in Amsterdam (Netherlands) between 31 May and 3 June 2014.


Kyowa Hakko Kirin
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