Reata Pharmaceuticals Inc. (NASDAQ: RETA) saw its shares kick off the week with an incredible gain after the company reported initial data from its mid-stage trial evaluating bardoxolone methyl (bardoxolone) in patients with chronic kidney disease.
Based on the results, Reata has initiated screening in the Phase 3 portion of the trial and is planning to launch additional Phase 2 studies in rare renal diseases during the first half of 2018.
The results ultimately demonstrated that bardoxolone significantly improved kidney function in Alport syndrome patients in terms of glomerular filtration rate. Over 80% of patients demonstrated a clinically meaningful improvement in that rate by week 8, with a 95% confidence interval at Week 12.
The observed treatment effect surpassed the minimum threshold that was necessary to proceed to the Phase 3 portion of the trial. At the same time, no serious adverse events have been reported in the trial, and reported adverse events have been generally mild to moderate in intensity.
Colin Meyer, M.D., chief medical officer of Reata, commented:
The ongoing Phase 2 portion of CARDINAL demonstrated clear improvements in renal function that are large in magnitude, occur in a high percentage of patients, and are highly statistically significant. These results exceeded our expectations and bring us one step closer to the prospect of bardoxolone becoming the first effective treatment for this severe and life-threatening disease. We are eager to study bardoxolone in additional, rare renal diseases driven by inflammatory processes that bardoxolone addresses.
Shares of Reata were last seen trading up about 20% at $37.30, with a consensus analyst price target of $45.60 and a 52-week range of $15.18 to $41.60.