Abbott pulls kidney disease trial
pharmafile | October 22, 2012 | News story | Research and Development, Sales and Marketing | Abbott, Reata, kidney
Abbott has terminated its Phase III trial of bardoxolone methyl in patients with kidney disease and diabetes after concerns over adverse events and deaths.
The BEACON trial, run with Texas-based Reata Pharmaceuticals, which discovered the drug, was looking at its performance in patients with stage 4 chronic kidney disease (CKD) and type II diabetes versus placebo.
The decision to pull the plug in all ongoing clinical trials with the drug in CKD came after an independent data monitoring committee said there were “safety concerns due to excess serious adverse events and mortality in the bardoxolone methyl arm”.
Reata and Abbott have notified regulatory agencies and patients have been told to stop taking the drug – although there has been no further public information on how many deaths there have been or what the adverse events were.
Analysts are wondering why BEACON has been snuffed out so suddenly. “Given the robustness of bardoxolone’s prior development programme, it is strange that no red flags had gone up earlier,” said EP Vantage.
It is hard to see the failure as anything but a severe blow for Abbott: this was one of the manufacturer’s most promising late-stage drugs, with the apparent potential to slow the progression of patients towards needing dialysis.
The hope had been that bardoxolone methyl might be on the market as early as 2014 – with analysts forecasting sales as high as $525m by 2018 – although this now appears unrealistic.
In a statement Reata said it would be “closely examining the data from this trial to determine if there is an appropriate path forward for the development of bardoxolone methyl in CKD or other indications and for our other AIM [antioxidant inflammation modulator] compounds”.
Abbott paid $450 million for rights to bardoxolone methyl in September 2010 – a fee which now looks way over the odds – and its pipeline still needs boosting as it faces US patent expiry of its biggest-seller – arthritis treatment Humira – in 2016.
The separate $400 million deal to jointly develop and commercialise Reata’s portfolio of second-generation, oral AIMs was signed by Abbott in December 2011.
Adam Hill
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