The termination of the BEACON trial - a phase 3 trial of Bardoxolone methyl in CKD - was announced October 18, 2012. Here is the announcement: "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."
The news is quite shocking because it is in stark contrast to the encouraging phase 2 results published by Pablo Pergola and colleagues in July 2011 in NEJM.
Not much else is in the news about the trial...except at American Society of Nephrology meeting (ASN) here in San Diego. The word that I am hearing is that the trial enrolled patients with more advanced kidney disease (stage 4) and that "patient's couldn't handle it". The question is whether something can be salvaged from the Bardoxolone methyl clinical development program. The short answer is no.
Amid the many REATA banners the ASN is abuzz about the news that one-half of the REATA workforce were laid off just prior to the ASN and that most of the remainder will be laid off after. Au Revoir REATA.
The news is quite shocking because it is in stark contrast to the encouraging phase 2 results published by Pablo Pergola and colleagues in July 2011 in NEJM.
Not much else is in the news about the trial...except at American Society of Nephrology meeting (ASN) here in San Diego. The word that I am hearing is that the trial enrolled patients with more advanced kidney disease (stage 4) and that "patient's couldn't handle it". The question is whether something can be salvaged from the Bardoxolone methyl clinical development program. The short answer is no.
Amid the many REATA banners the ASN is abuzz about the news that one-half of the REATA workforce were laid off just prior to the ASN and that most of the remainder will be laid off after. Au Revoir REATA.
