Phase 3 Clinical Trial of CKD Drug Bardoxolone Halted on Safety Concerns

Reata Pharmaceuticals announced yesterday (Oct 18, 2012) that it has decided to terminate the phase 3 clinical trial of Bardoxolone methyl [BEACON] for treatment of patients with stage 4 kidney disease and type 2 diabetes.  Abbott is co-developing Bardoxolone and has  the rights to develop this drug outside the US market.  Bardoxolone has generated a lot of interest within the nephrology community, since there have been no new safe and effective treatments to slow or reverse the progression of CKD other than ACE inhibitors or angiotensin receptor blockers.  I had previously reported on the results of the phase 2 dose ranging trial of Bardoxolone that had shown some safety concerns including muscle spasms, hyperkalemia and hypomagnesemia.  But the new finding of increased mortality in the active treatment arm were unexpected.

The company announcement can be found here [Reata-Bardoxolone] and below:

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.

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