Concerns about excess serious adverse events and mortality in patients taking bardoxolone methyl
Abbott Laboratories suffered a late-stage pipeline blow yesterday after partner Reata Pharmaceuticals was forced to halt all trials of a kidney disease drug on safety concerns.
Bardoxolone methyl was being studied in a phase III trial designed to show if it could delay progression to end-stage renal disease (ESRD) and cardiovascular death in patients with chronic kidney disease and type 2 diabetes.
The decision to halt the study - called BEACON - was taken following a recommendation from the trial's independent data monitoring committee which said it was concerned about "excess serious adverse events and mortality in the bardoxolone methyl arm".
All other clinical trials of the drug have also been suspended and Reata and Abbott have notified regulatory agencies of the decision.
While Reata has said it is exploring the data to see if there is a way forward for bardoxolone methyl, the clinical shutdown suggest any chance that the drug could fulfil its potential as a blockbuster-in-waiting are over.
Abbott licensed ex-US marketing rights to bardoxolone methyl from Reata in 2010 in a $450m deal, and chief executive Richard Gonzalez has held it up in the past as one of the primary pipeline assets for AbbVie, the pharma business that is set to be spun out from Abbott by the end of the year.
Just ahead of the announcement, analysts at Credit Suisse had suggested that bardoxolone methyl had "game-changing potential" and could garner peak sales of $2.4bn to $3bn, whilst noting that the project was "not without its risks".
Shares in Abbott fell around 5 per cent on the announcement to close at $66.64 yesterday. Meanwhile, Japanese drugmaker Kyowa Hakko Kirin, which has rights to the drug in some Asian markets, slumped more than 6 per cent.