Navigation Links
Reata and Abbott Initiate Global Phase 3 Study of Bardoxolone Methyl in Patients With Chronic Kidney Disease and Type 2 Diabetes
Date:6/16/2011

IRVING, Texas and ABBOTT PARK, Ill., June 16, 2011 /PRNewswire/ -- Reata Pharmaceuticals, Inc. and Abbott announced today 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 www.clinicaltrials.gov (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 www.reatapharma.com.

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 www.abbott.com.


'/>"/>
SOURCE Abbott
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Public Forum to Discuss Addiction as a Treatable Disease and Highlight National Alcohol and Drug Addiction Recovery Month
2. Oxford Finance Corporation Facilitates Entry for Reata Pharmaceuticals into Asian Markets
3. Abbott and Reata Pharmaceuticals Announce Agreement to Develop and Commercialize Bardoxolone Methyl for Chronic Kidney Disease Outside the U.S.
4. Reata Pharmaceuticals to Present Data from Pivotal Phase 2b Trial in Type 2 Diabetics With Chronic Kidney Disease
5. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
6. Abbott and AstraZeneca Announce Selection of Next-Generation Fenofibrate ABT-335 and CRESTOR(R) Fixed-Dose Combination
7. Abbott Initiates Clinical Study to Evaluate Use of RX Herculink(R) Elite(TM) Renal Stent System for the Treatment of Renal Artery Stenosis
8. Abbotts ABT-874 Shows Positive Results for Maintenance of Response in Phase II Psoriasis Study
9. Abbotts XIENCE(TM) V Everolimus Eluting Coronary Stent Shows Continued Superiority to TAXUS Stent in Reducing Major Adverse Cardiac Events in SPIRIT III Clinical Trial
10. Abbott Announces Positive One-Year Results from the Worlds First Clinical Trial of a Fully Bioabsorbable Drug Eluting Coronary Stent
11. Abbotts m2000(TM) Molecular Diagnostic Instrument and RealTime HIV-1 Test Win Chicago Innovation Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... Denmark , Oct. 2, 2017 The Rebound ... in the struggle to reverse the tide of prescription drug ... for regulating their medicine intake and stepping down their dosage ... set to launch in December 2017; the first 100,000 people ... Learn more at http://www.rebound-solution.com/ ...
(Date:9/28/2017)... 28, 2017 Cohen Veterans Bioscience and Early ... of wearable and home sensors for real-time monitoring of ... Foundation, a nonprofit organization focused on disruptive health solutions ... affordable analytical system to record and integrate behavioral, cognitive, ... ...
(Date:9/27/2017)... and NEW YORK , Sept. 27, 2017  DarioHealth ... and big data solutions, today announced that its MyDario product is expected ... local TV listings for when The Dr. Oz Show airs in your ... The nine-time Emmy ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... ... agency serving communities in the greater Dallas, Miami, and Raleigh regions, is organizing ... fighting to overcome a rare and deadly chromosome abnormality. , After struggling since ...
(Date:10/13/2017)... IL (PRWEB) , ... October 13, 2017 , ... ... which established the certification process to promote standards of excellence for the field ... Symposium, scheduled for March 22 – 25, 2018 in Orlando, Florida at the ...
(Date:10/13/2017)... ... October 13, 2017 , ... Many families have long-term insurance that ... insurance companies have a waiver for care if the client has a cognitive impairment ... family pays for care, is often waived, so the benefits from their insurance start ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob ... sciatica in a new episode of "Success Files," which is an award-winning educational ... and investigates each subject in-depth with passion and integrity. , Sciatica occurs when ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and ... apnea using cutting-edge Oventus O2Vent technology. As many as 18 million Americans ... frequent cessation in breathing. Oral appliances can offer significant relief to about 75 ...
Breaking Medicine News(10 mins):