Reata’s bardoxolone hits goals in phase 2 kidney disease trial

Reata Pharmaceuticals’ bardoxolone has improved kidney function in patients with IgA nephropathy and Type 1 diabetic chronic kidney disease (CKD). The phase 2 trial linked the Nrf2 activator to improvements in estimated glomerular filtration rate (eGFR), a measure of kidney damage.

Bardoxolone has had an eventful eight years. In 2010, Abbott committed $450 million in upfront and near-term milestones for the ex-U.S. rights to the drug. Two years later, the discovery of an increased death rate among people taking bardoxolone brought the program screeching to a halt. Since then, Reata has worked to get bardoxolone back on track, culminating in data drops that have sent its stock up by more than 180% over the past year.

The latest results come from the IgA nephropathy and Type 1 diabetic CKD cohorts of a phase 2 trial that assessed bardoxolone in patients with a range of rare kidney diseases. The trial linked the drug to improved eGFR in both populations.

After 12 weeks of daily treatment with bardoxolone, eGFR in the 26 IgA nephropathy patients had increased by 8.0 mL/min/1.73 m2. That's compared to an average annual decline of 1.2 mL/min/1.73 m2 before the start of the study. Reata calculated the post-treatment turnaround recovered six years of eGFR loss. The eGFR result was statistically significant with a p value of less than 0.0001.

Reata saw a similar, albeit less dramatic, trend in the 28 Type 1 diabetic CKD patients. The eGFR of these patients increased by 5.5 mL/min/1.73 m2, which amounts to a recovery of roughly three years of eGFR loss.   

The study is small and the improvements are compared to baseline, not a placebo-controlled arm. But with the safety data also coming in clean, Reata thinks it has the makings of a drug that can help people with an array of kidney diseases.

"With these data, bardoxolone has improved kidney function in multiple rare forms of CKD, including Alport syndrome, autosomal dominant polycystic kidney disease, IgA nephropathy and Type 1 diabetic CKD," Reata CMO Colin Meyer, M.D., said in a statement.

Reata’s work in the area is spearheaded by a phase 2/3 trial in patients with Alport syndrome. A phase 3 trial of bardoxolone in connective tissue disease associated pulmonary arterial hypertensionis also underway.

Shares in Reata rose 12% in premarket trading.

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