Bardoxolone methyl is a small-molecular compound licensed from
'We are pleased that we have submitted an NDA of bardoxolone methyl for Alport Syndrome, a serious, progressive disease with an unmet need for new therapeutic options,' said
This application is based on the efficacy and safety data from the CARDINAL Phase 3 clinical trial, which was conducted by Reata for patients with Alport Syndrome. The primary efficacy endpoints of the study were the changes from baseline in estimated glomerular filtration rate (eGFR) at Week 48 and Week 100 after the start of the drug administration. At both time, significant improvements in eGFR were observed in bardoxolone methyl group relative to the placebo group.
About Bardoxolone Methyl
Bardoxolone methyl is a small-molecular compound that activates nuclear factor erythroid 2- related factor 2 (Nrf2), a transcription factor that has a key role in the body's protective response to stress. A wide range of anti-oxidative and anti-inflammatory effects of this compound could improve kidney function. In the phase 2 clinical study conducted in
About Alport Syndrome
Alport Syndrome is a progressive genetic disease that causes hematuria, proteinuria and decreased renal function, and is one of the intractable diseases designated by the
About CARDINAL study
CARDINAL was a phase 2/3 study in patients with Alport Syndrome aged 12-70 years and with baseline eGFR of 30-90 mL/min/1.73m2 . The Phase 3 portion of CARDINAL was an international, randomized, placebo-controlled, double-blind study, and the change from baseline in eGFR was evaluated at Weeks 48, 52, 100, and 104 after the start of the drug administration. For these endpoints, the mean values for bardoxolone methyl group were significantly higher than those for the placebo group at each time point, indicating a clinically meaningful improvement in eGFR.
About eGFR
Abbreviation of estimated glomerular filtration rate. Although the inulin-clearance method, the gold standard for measuring GFR, is used in case of need for an accurate evaluation of kidney function for such as kidney transplant donor, eGFR based on the serum creatinine level is widely used to assess kidney function in clinical practice
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