Reata Pharmaceuticals and Abbott Laboratories have reported positive results from a Phase IIb study of bardoxolone methyl, its investigational treatment for chronic kidney disease.
The results suggest that bardoxolone methyl may reduce the severity of the disease, and improve estimated glomerular filtration rate and other measures of kidney function in a majority of patients.
Around 60% of the patients treated with bardoxolone methyl experienced a reduction in the classification of the severity of their disease after 24 weeks of treatment, compared to 17% of the patients in the placebo group.
At week 24, patients receiving bardoxolone methyl had a mean increase in estimated glomerular filtration rate of more than 10 ml/min/1.72m², compared with no change in the placebo-receiving patients
The multi-centre, double-blind, randomised clinical trial involved 227 patients with moderate (stage IIIb) to severe (stage IV) chronic kidney disease and type II diabetes.
The patients were randomised to receive once-daily dose of placebo or 25mg, 75mg or 150mg doses of bardoxolone methyl, and the primary endpoint of the study was change in glomerular filtration rate after 24 weeks of treatment.