Study of Abbott,Reata Kidney-Disease Drug Stopped Over Safety Concerns 10/18 09:36 AM
Abbott Laboratories (ABT:$65.16,00$-3.88,00-5.62%) said Thursday a clinical trial of an experimental treatment for kidney disease was discontinued due to safety concerns including an excessive death rate among the drug's users.
Abbott was informed of the trial's discontinuation Wednesday by its partner for the drug, Reata Pharmaceuticals Inc., Abbott said in a filing with the Securities and Exchange Commission. Reata confirmed the news in a separate statement.
Abbott licensed rights for the drug, bardoxolone, outside the U.S. from Reata in 2010.
According to Abbott, Reata discontinued a late-stage, or Phase 3, study evaluating bardoxolone in patients with advanced chronic kidney disease and Type 2 diabetes.
The discontinuation was based on a recommendation by the study's independent data monitoring committee, due to "excess serious adverse events and mortality in the bardoxolone methyl arm." The drug was being compared with a placebo, according to clinicaltrials.gov.
Abbott said regulatory agencies have been notified, and study sites and study participants are being informed.
The companies will review the data to determine whether there is an appropriate path forward for development of the drug in chronic kidney disease or other potential uses.