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Bardoxolone blow up: Phase II signals presaged surprise in sicker CKD patients
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Reata, AIM, backfire
Monday, October 29, 2012
The decision to move Reata
Pharmaceuticals Inc.'s bardoxolone into sicker kidney disease patients
in Phase III may have been intended to get to results faster. Instead, the move
may have amplified toxicity signals seen in Phase II patients with less
On Oct. 18, Reata said it would
stop all studies in chronic kidney disease (CKD), including the Phase
III BEACON trial in Type II diabetics with CKD, because of an excess of serious
adverse events and mortality in the treatment group.
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