Reata strives to translate innovative science into breakthrough
medicines for intractable diseases.
Company Statement: Termination of the
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
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.