Reata Announces Receipt of $30-Million Milestone Payment
Reata Pharmaceuticals, Inc. recently announced it has received a $30-million milestone payment from its licensee, Kyowa Hakko Kirin Co., Ltd. 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.
Bardoxolone is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. The FDA has granted Orphan Drug designation to bardoxolone for the treatment of Alport syndrome and pulmonary arterial hypertension. The European Commission has granted Orphan Drug designation in Europe to bardoxolone for the treatment of Alport syndrome. In addition to CARDINAL and AYAME, bardoxolone is currently being studied in CATALYST, a Phase 3 study for the treatment of connective tissue disease associated pulmonary arterial hypertension, and PHOENIX, a Phase 2 study for the treatment of autosomal dominant polycystic kidney disease, IgA nephropathy, focal segmental glomerulosclerosis, and CKD associated with type 1 diabetes.
Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata’s two most advanced clinical candidates, bardoxolone and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. For more information, visit www.reatapharma.com.
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