A late-stage trial of Abbott and partner Reata Pharmaceuticals’ bardoxolone in patients with stage 4 chronic kidney disease and type 2 diabetes has been terminated on fears over safety.
The move to pull the plug on the Phase III BEACON trial came after an Independent Data Monitoring Committee said “excess serious adverse events and mortality” were observed in patients taking the drug.
Further information has not been released at this point, but Reata said it would now closely examine data from the trial “to determine if there is an appropriate path forward for the development of bardoxolone methyl in chronic kidney disease or other indications”.
Bardoxolone is an oral, first-in-class antioxidant inflammation modulator that works by increasing the estimated glomerular filtration rate (eGFR) of the kidneys.
In two Phase II trials, it significantly improved kidney function in patients with advanced CKD and type 2 diabetes.
So news of the safety issues unsurprisingly left a bitter taste in investors’ mouths, particularly as bardoxolone was considered an important asset and future revenue stream for the Abbott, which is grappling with patent losses.
“This is certainly a negative for Abbott, as this development programme was, along with Hep-C, one of two potential multi-billion dollar pipeline opportunities,” said JPMorgan Chase analyst Michael Weinstein, according to Bloomberg.
Abbott’s stock dipped about 6% after news of the trial’s cessation emerged.
