Reata Pharmaceuticals, Inc. (Nasdaq:RETA), a clinical-stage biopharmaceutical company, today announced that it has received a $30 million milestone payment from its licensee, Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin), following the initiation of AYAME, a Phase 3 clinical trial to assess the efficacy and safety of bardoxolone methyl (bardoxolone) for the treatment of diabetic kidney disease in Japan.
In December 2009, Reata granted Kyowa Hakko Kirin the exclusive license to develop and commercialize bardoxolone in renal disease and certain other indications in Japan, China, Taiwan, South Korea, and Southeast Asia. Last year, Kyowa Hakko Kirin reported positive results from the Phase 2 TSUBAKI trial of bardoxolone in patients with type 2 diabetes and chronic kidney disease. The pivotal AYAME trial began in May of this year and will enroll an estimated 700 diabetic kidney disease patients, with an estimated study completion date of March 2022. Kyowa Hakko Kirin is also collaborating with Reata in Japan on the ongoing Phase 3 CARDINAL trial of bardoxolone for the treatment of Alport syndrome, a severe, hereditary form of chronic kidney disease.
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