Reata to re-file bardoxolone with FDA following positive Ph III data

US biotech Reata Pharmaceuticals (Nasdaq: RETA) says it will seek Food and Drug Administration approval for what would be the first drug to reverse kidney damage and prevent the need for dialysis or transplant.

Reata’s data are in patients with a rare genetic form of chronic kidney disease (CKD) known as Alport syndrome (AS). Notwithstanding what seems to be a positive development, Reata’s shares fell 7.8% to $197.00 in post-market trading on Monday.

New data from a registrational Phase III study shows drug candidate, bardoxolone (bard), met its primary endpoint of improving estimated glomerular filtration rate (eGFR), a measure of kidney function. Patients had a 9.5 ml/min improvement in eGFR compared to placebo after 48 weeks of daily bard treatment. Even when patients were removed from drug for four weeks, eGFR was still improved 5.14 ml/min, indicating that bard is having a true disease modifying effect.