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New Phase 2 Data Published in New England Journal of Medicine Show Bardoxolone Methyl Sustained Improvement in Measure of Kidney Function (eGFR) Over 52 Weeks in Patients With Moderate to Severe Chronic Kidney Disease and Type 2 Diabetes
Date:6/24/2011

IRVING, Texas and ABBOTT PARK, Ill., June 24, 2011 /PRNewswire/ -- New Phase 2 clinical trial data published online today in The New England Journal of Medicine show that patients with moderate to severe chronic kidney disease and type 2 diabetes receiving bardoxolone methyl for 52 weeks experienced a sustained improvement in kidney function throughout the treatment period, as measured by estimated glomerular filtration rate (eGFR). The data were also presented today in a Late-Breaking Clinical Trials session at the 2011 European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Congress in Prague, Czech Republic.

The Phase 2 dose-finding clinical trial, known as the BEAM study, showed that in patients with moderate to severe chronic kidney disease – defined by an eGFR of 20 to 45 mL/min/1.73m2 – and type 2 diabetes, eGFR at 52 weeks was significantly improved with bardoxolone methyl treatment by up to 10.5 mL/min/1.73m2 in patients receiving 75 mg (p<0.001).

"The published data for bardoxolone methyl suggest that it may have potential to delay kidney disease progression in patients with compromised kidney function," said Dr. David Warnock of the University of Alabama at Birmingham, who presented the findings at the ERA-EDTA session and is the senior author of the article.  "Further study to learn more about the clinical benefits of this drug candidate is warranted."

The multi-center, double-blind, placebo-controlled trial enrolled 227 patients who were randomly assigned to receive placebo, 25, 75 or 150 mg of bardoxolone methyl orally, once daily for 52 weeks.

Specifically, the 52-week data showed:

  • At 52 weeks, patients receiving each of the three tested doses of bardoxolone methyl experienced a statistically significant improvement in eGFR, an important measure of kidney function. Increases were 5.8, 10.5 and 9.3 mL/min/1.73m2 for the 25, 75
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SOURCE Abbott
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