Reata, in consultation with the BEACON Steering Committee, has decided to terminate the Phase 3 BEACON trial of bardoxolone methyl in patients with stage 4 chronic kidney disease and type 2 diabetes. This decision was made based upon a recommendation of the Independent Data Monitoring Committee (IDMC) to stop the trial "for safety concerns due to excess serious adverse events and mortality in the bardoxolone methyl arm."
Clinical trial sites have been notified, and patient participants are being instructed to stop taking study drug and return to the clinic for a final visit. In addition, Reata and Abbott have notified the FDA and other regulatory agencies of the decision to stop the clinical trial and all ongoing clinical trials with bardoxolone methyl in CKD.
We will continue our commitment to patient safety and developing medicines for intractable diseases by closely examining the data from this trial to determine if there is an appropriate path forward for the development of bardoxolone methyl in chronic kidney disease or other indications and for our other AIM compounds.
For information on BEACON and other previous clinical trials with Bardoxolone Methyl, click here.
Reata Pharmaceuticals, Inc.