|Reata Pharmaceuticals, Inc. Receives Orphan Drug Designation for Bardoxolone Methyl for the Treatment of Alport Syndrome|
Earlier this year, Reata initiated a Phase 2/3 clinical study to evaluate bardoxolone methyl (“bardoxolone”) in patients with chronic kidney disease (“CKD”) caused by Alport syndrome. The purpose of the study is to determine if Alport syndrome patients experience improvements in kidney function similar to those observed in multiple, previous trials of bardoxolone in patients with other forms of CKD. Reata expects data from the Phase 2 portion of the trial to be available by year-end 2017.
"This orphan designation is an important milestone for the Company and for Alport syndrome patients. There are currently no
Orphan status is granted to treatments for diseases that affect fewer than 200,000 people in
About Alport Syndrome
Alport syndrome is a rare, genetic form of CKD caused by mutations in the genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane (“GBM”) in the kidney. The abnormal expression of type IV collagen causes loss of GBM integrity, abnormal leakage of proteins through the GBM, and excessive reabsorption of protein in the proximal tubules of the kidney. Like other forms of CKD, excessive reabsorption of protein in the tubules induces oxidative stress, chronic inflammation, and renal interstitial inflammation and fibrosis.
Alport syndrome affects approximately 12,000 people in
About Bardoxolone Methyl
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. Bardoxolone is currently being studied in CATALYST, a Phase 3 clinical trial in patients with connective tissue disease associated pulmonary arterial hypertension (CTD-PAH).
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 to restore mitochondrial function, reduce oxidative stress, and resolve inflammation.
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