Reata, Kyowa Kirin End Bardoxolone CKD Development

Missed Secondary Endpoint In Japan Trial

 
• By Lisa Takagi

Reata was expecting positive results from a Phase III study by Japanese licensee for diabetic kidney disease after a US rejection for Alport Syndrome last year, but the US company and Asia partner Kyowa Kirin have now decided to end development in CKD indications after a missed secondary endpoint seen as critical to approval in Japan. 

Kyowa Kirin / Reata
Kyowa Kirin’s decision to withdraw from Japanese development set to impact bardoxolone’s US pathway • Source: Shutterstock

Reata Pharmaceuticals, Inc. has been hit by a decision with its APAC partner Kyowa Kirin Co., Ltd. to discontinue the development of its Nrf2 activator bardoxolone (RTA 402) for diabetic kidney disease in Japan, after the Phase III AYAME study missed a key secondary endpoint.

The Japanese firm has also withdrawn a July 2021 approval filing for the separate indication of Alport syndrome, and

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