Kyowa Hakko Kirin Announces New, Future Direction Of Kidney Disease Treatment
By Lori Clapper
Kyowa Hakko Kirin announced today it plans to take its small molecule compound bardoxolone methyl in a new direction, starting with a new Phase 2 clinical study on the molecule, which is currently licensed from Reata Pharmaceuticals.
In November 2013, the company discontinued its clinical studies on the drug, after increased risks for heart failure were observed in the Phase 3 placebo-controlled comparative clinical studies in chronic kidney disease (CKD) patients with type 2 diabetes. These risks were mostly observed in patients in the bardoxolone methyl arm of the study.
“Although inhibitors of the renin–angiotensin–aldosterone system can slow the progression of diabetic kidney disease, the residual risk is high. In the bardoxolone methyl group, ESRD developed in 43 patients, and 27 patients died from cardiovascular causes; in the placebo group, ESRD developed in 51 patients, and 19 patients died from cardiovascular causes,” according to a December 2013 article in the New England Journal of Medicine.
This particular research was conducted by Reata in the U.S., Europe, Canada, Australia, and Central America (the BEACON study).
Kyowa Hakko Kirin, which completed a detailed analysis of the BEACON study data and consultations with the Pharmaceuticals and Medical Devices Agency (PMDA), announced it will continue developing this compound for CKD patients with type 2 diabetes. However, they stress that patient safety is the company’s primary concern. The company also plans to evaluate both the safety and efficacy of bardoxolone methyl in this new Phase 2 clinical study to be performed in Japan.
In December 2009, Reata signed over exclusive rights to Kyowa Hakko Kirin to develop and commercialize bardoxolone methyl in Japan, China, Taiwan, Korea, and Southeast Asia. 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.