Reata and Abbott Announce Positive Phase 2b Study Results for Bardoxolone MethylBy Abbott, PRNE
Friday, November 19, 2010
Results Suggest Bardoxolone Methyl May Reduce the Stage of Disease and Improve Measures of Kidney Function in Patients with Chronic Kidney Disease and Type 2 Diabetes
IRVING, Texas and ABBOTT PARK, Illinois, November 20, 2010 - Reata Pharmaceuticals and Abbott (NYSE: ABT) today announced data from a
Phase 2b study which suggests that bardoxolone methyl, an investigational
treatment for chronic kidney disease (CKD), may reduce the stage of CKD and
improve estimated glomerular filtration rate (eGFR) and other measures of
kidney function in the majority of patients receiving the drug. The data were
presented today in a late-breaking oral presentation at the American Society
of Nephrology (ASN) Renal Week Conference in Denver, Colorado.
The study evaluated patients with moderate (stage 3b) to severe (stage 4)
CKD and type 2 diabetes. Approximately 60 percent of the patients receiving
bardoxolone methyl experienced a reduction in the classification of the
severity of their disease after 24 weeks of treatment. Only 17 percent of
patients in the placebo group experienced such a reduction. Additionally,
only four percent of patients in each bardoxolone methyl group experienced a
worsening of CKD stage compared to 13 percent in the placebo group.
"Chronic kidney disease is a significant health problem in the U.S., as
the standard of care slows but does not reverse progression of the disease,"
said Pablo Pergola, M.D., Ph.D., Research Director for Renal Associates PA
and Clinical Associate Professor of Medicine at the University of Texas
Health Science Center at San Antonio, who presented the data. "These
encouraging results suggest that bardoxolone methyl has the potential to
change the treatment landscape of chronic kidney disease and offer new hope
for these patients and their families."
The multi-center, randomized, double-blind clinical trial enrolled 227
CKD patients with type 2 diabetes who were randomized to receive once-daily
doses of placebo or 25, 75 or 150 mg doses of bardoxolone methyl. The primary
endpoint of the study was change in estimated GFR following 24 weeks of
At week 24, patients treated with bardoxolone methyl experienced a mean
increase in estimated GFR of over 10 mL/min/1.72m2, compared with no change
in the placebo group. Approximately three-quarters of bardoxolone methyl-
treated patients experienced an improvement in eGFR of 10 percent or more,
including one-quarter who saw an improvement of 50 percent or more compared
to less than two percent of patients on placebo. (p<0.001).
The frequency of adverse events was higher in the bardoxolone methyl
group compared to the placebo group, with most events mild to moderate in
severity. The most frequently reported adverse event in the bardoxolone
methyl group was muscle spasm.
"We are very pleased to see that bardoxolone methyl reduced the stage of
disease and improved measures of kidney function in the majority of patients
receiving the drug," said Warren Huff, CEO of Reata. "We are hopeful that
these results will be further validated at the end of the study, and we look
forward to initiating a Phase 3 study in the first half of 2011."
"Extensive preclinical and clinical experience with bardoxolone methyl
have suggested this drug holds promise as a new approach for the treatment
for CKD - one that has the potential to help prevent patients from
progressing to the later stages of the disease and dialysis," said Eugene
Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "We
look forward to expanding our knowledge further in future studies."
About Bardoxolone Methyl
Bardoxolone methyl is an antioxidant inflammation modulator (AIM) that
activates Nrf2, thereby inducing the transcription of genes that decrease the
level of oxidative stress and suppress important inflammatory mediators. In
two Phase 2a studies, bardoxolone methyl was shown to increase measures of
kidney function in patients with moderate to severe CKD and Type 2 diabetes.
About Chronic Kidney Disease
Chronic kidney disease (CKD) is a progressive loss of kidney function
over a period of months or years, which can be caused by a number of
conditions, including diabetes and high blood pressure. Diabetes is one of
the leading causes of CKD. CKD is a highly prevalent condition, worldwide,
with numbers expected to rise over the next decade. Available therapies
modestly slow the progression of CKD, and patients ultimately progress to
About Reata Pharmaceuticals
Reata Pharmaceuticals is the leader in discovering and developing novel,
oral anti-inflammatory drugs that activate Nrf2, the primary regulator of
cellular antioxidant and detoxification enzymes. Activation of this important
biological target protects against a broad range of diseases associated with
inflammation and oxidative stress. Reata is developing bardoxolone methyl,
its lead product candidate, as the first disease-modifying treatment for
chronic kidney disease. In January 2010, Reata and Kyowa Hakko Kirin
announced a licensing agreement providing KHK with the exclusive rights to
develop and commercialize bardoxolone in Japan and other selected Asian
markets. In September 2010, Reata formed a strategic partnership with Abbott
for the commercialization of bardoxolone in other ex-U.S. markets. Reata
retains exclusive rights to bardoxolone in the U.S.
For more information please visit the company's Website at
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacturing and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs nearly 90,000 people and markets its products in more than
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
Media, Heidi Chokeir, +1-619-528-2217, heidi.chokeir at russopartnersllc.com, or Investors, Alan Roemer, +1-646-378-2945, aroemer at troutgroup.com, both for Reata Pharmaceuticals; or Media, Tracy Sorrentino, +1-847-937-8712, tracy.sorrentino at abbott.com, or Financial, Larry Peepo, +1-847-935-6722, larry.peepo at abbott.com, both of Abbott
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