Reata and Abbott Initiate Global Phase 3 Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes
By Abbott, PRNEWednesday, June 15, 2011
IRVING, Texas and ABBOTT PARK, Illinois, June 16, 2011 -
- Pivotal clinical trial
will further assess drug candidate’s effect on kidney function
-
Reata
Pharmaceuticals, Inc. and
the initiation of a pivotal Phase 3 clinical trial to evaluate the
safety and efficacy of bardoxolone methyl in patients with chronic
kidney disease (eGFR of 15-29 mL/min/1.73 m2) and type 2
diabetes.
The trial, known as BEACON (Bardoxolone methyl
EvAluation in patients with Chronic kidney
disease and type 2 diabetes: the Occurrence of renal
eveNts), is the first multinational, double-blind,
placebo-controlled study designed to assess the impact of
bardoxolone methyl on time to important clinical outcomes.
Approximately 1,600 patients at 300 sites worldwide - including in
Austria, Australia, Belgium, Canada, Czech Republic, France,
Germany, Israel, Italy, Mexico, Spain, Sweden, United Kingdom and
United States - will be enrolled in the trial and randomized
1:1 to receive 20 mg of a reformulated version of bardoxolone
methyl or placebo once daily. Results are expected in
2013.
The primary efficacy endpoint will be a time-to-first-event
composite consisting of progression to end-stage renal disease
(ESRD), defined as the need for chronic dialysis or renal
transplant, and cardiovascular death. Secondary endpoints will
include change in estimated glomerular filtration rate (eGFR) and a
time-to-first-event composite consisting of hospitalization for
congestive heart failure (CHF), non-fatal myocardial infarction
(MI), non-fatal stroke and cardiovascular death.
More information on the trial is available at
(clinical trial identifier: NCT01351675).
“We are pleased to announce that the Phase 3 BEACON trial is
underway,” said Pablo E. Pergola, M.D., Ph.D., Director of Renal
Associates’ Research Division in San Antonio, Texas, who screened
the first patient of the study. “There are few therapeutic options
available today that slow the progression of CKD. Results from the
Phase 2 BEAM trial suggest that bardoxolone methyl may improve
measures of kidney function in patients with moderate to severe CKD
and Type 2 diabetes. We look forward to further evaluating
the drug candidate’s effects on clinical outcomes in this patient
population.”
Final results from the 52-week Phase 2b BEAM study will be
presented during a Late-Breaking Clinical Trials session on June 24
at the 2011 European Renal Association-European Dialysis and
Transplant Association (ERA-EDTA) Congress in Prague, Czech
Republic.
About Chronic Kidney Disease
Chronic kidney disease (CKD) is a progressive loss of kidney
function over a period of months or years that can be caused by a
number of conditions, including diabetes and high blood pressure.
CKD is a highly prevalent condition worldwide with numbers expected
to rise over the next decade. In the United States there are more
than 26 million patients with CKD, and more than 500,000 patients
with ESRD.
About Bardoxolone Methyl
Bardoxolone methyl is a novel, first-in-class antioxidant
inflammation modulator (AIM). Bardoxolone methyl is an Nrf2
activator, thereby inducing the transcription of genes that reduce
oxidative stress and suppress important inflammatory mediators.
In January 2010, Reata and Kyowa Hakko Kirin (KHK) announced a
licensing agreement providing KHK with the exclusive rights to
develop and commercialize bardoxolone methyl in Japan and other
selected Asian markets. In September 2010, Reata formed a strategic
partnership with Abbott for the commercialization of bardoxolone
methyl in other ex-U.S. markets. Reata retains exclusive
rights to bardoxolone methyl in the U.S.
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
therapy specifically intended to improve or preserve kidney
function.
For more information please visit the company’s Web site at
About Abbott
Abbott (NYSE: ABT) 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 130 countries.
Abbott’s news releases and other information are available on
the company’s Web site at
Reata Contacts, Media, Matt Middleman, +1-212-845-4272, matt.middleman at russopartnersllc.com, or David Schull, +1-212-845-4271, david.schull at russopartnersllc.com, or Investors, Alan Roemer, +1-646-378-2945, aroemer at troutgroup.com; or Abbott Contacts, Media, Raquel Powers, 1-847-935-6563, raquel.powers at abbott.com, or Financial, Larry Peepo, +1-847-935-6722, larry.peepo at abbott.com
Tags: Abbott, Illinois, Irving, June 16, texas, Texas And Abbott Park
