Kyowa Hakko drops Ph II study of bardoxolone

Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) says it is discontinuing its Phase II clinical studies evaluating a small molecule compound, bardoxolone methyl (RTA 402) licensed from privately-held USA-based Reata Pharmaceuticals, in chronic kidney disease (CKD) patients with type 2 diabetes in Japan.

In the meantime, Kyowa Hakko Kirin has been considering a new development program of bardoxolone methyl (RTA 402) in CKD patients with type 2 diabetes.

In October 2012, Reata discontinued the Phase III clinical study, known as BEACON, designed to evaluate bardoxolone methyl in CKD patients with type 2 diabetes in the USA, Europe, Canada, Australia and Central America. The decision was made based on a recommendation of the Independent Data Monitoring Committee (IDMC) to stop the study "for safety concerns due to excess serious adverse events and mortality in the bardoxolone methyl arm." The results of the BEACON study were presented at the American Society of Nephrology's 2013 Annual Meeting (November 7-10, in Atlanta, Georgia, USA) and published in The New England Journal of Medicine.