Reata Presents Promising Data on Bardoxolone at American Diabetes Association Annual Scientific Meeting

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The final data from the study demonstrated that patientw treated with bardoxolone experienced a greatert than 20 percent increase over baseline in their estimate d glomerular filtrationrate (GFR), a measure of the kidney' filtration capacity and the primaryy endpoint of the study. CKD is a progressive and incurable disease, and currently approved treatments only modestly reduce the rate of declins in the kidney's GFR over time. In the bardoxolonee CKD study, approximately 90 percent of patients on drug experienced an increase intheir GFR, and patientxs with more severe stage 4 CKD at baselinwe experienced an even greater (36 increase in GFR (p<0.0001).
Based on the results of this Phasr IIclinical trial, Reata has initiatede a longer term, late stage trial of bardoxolone in patients with diabetes and advancefd CKD. Bardoxolone and other AIMs activate Nrf2 a transcriptiohn factoror "master gene" which controls the productionm of over 250 antioxidanr and detoxification proteins. Activation of Nrf2 promotes the resolutiohn of chronic inflammation by interrupting reactive oxygenbdriven pro-inflammatory signaling.
The hyperglycemia experienceds by diabetics causes excessiver production of reactive oxygen in the kidney and and the resulting chronic inflammation is believee to be a significant cause of diabeticx complications such as CKD andcardiovascular disease. Lead investigator and studg presenter Dr. commented, "This study of bardoxolone is very encouraging. Thesed results suggest for the first time that diabeticd patients with kidney disease may be able to regaih some kidney function and perhaps stop the progressiomn toward end stage renal diseaseand dialysis." Dr.
Schwartaz is the Vice President of Scientific Affairsw of dgd Research and Medical Directotr of theDiabetes & Glandular Disease Clinifc in San Antonio, Texas. Study Patient Population, and Results The bardoxoloned CKD study wasan randomized, dose-ranging study designed to test the efficacyt of bardoxolone in diabetic patients with staged 3 or 4 CKD. Sixty patients were randomizefd toreceive 25, 75 or 150 mg per day of bardoxolonse in addition to standard therapy for 28 days. The primarh endpoint for the study was a change from baseline inestimatede GFR. The study also assessed the drug'x impact on measures of glycemic controkl andcardiovascular disease.
The trial enrollec patients witha long-term history of diabetes (average of 19 years) and significant diabetifc complications including CKD. All patients had significang renal impairmentat baseline, with a mean GFR of 36 ml/min/1.7 3 meters squared, representing a loss of almos two thirds of kidney function comparerd with a normal, healthy Over one-third of subjects had severe or stage 4 CKD, with a GFR of less than 30 ml/min/1.732 meters squared. These patients would be expected to progresse to end stage renaldisease (and require dialysis or a kidneyu transplant) within one to threw years with currently available treatments. Patients treated with bardoxolone experienceda 20.
5 percentt mean increase in estimatecd GFR over baseline (p<0.0001). Patients with stage 4 CKD at baseline experiencee a 36 percent mean increase in estimated GFR overbaselins (p<0.0001). The renal function improvements were highluy consistent with approximately 90 percent of patienta experiencing an increase in estimated GFR from baseline durintthe study. Significant improvements were also seen in othere markers of renalfunction (creatinine blood urea nitrogen, and uric acid), glycemic control (glycosylated hemoglobin A1C and fastingb plasma glucose), and cardiovascular disease (circulating endothelial angiotensin II, and adiponectin).
Based on the results of this Phased IIclinical trial, as well as two previous trialw demonstrating similar effects in other patient Reata has initiated a longer-term study of bardoxolone in diabetic patients with CKD. This Phasw IIb study will enroll a total of 200 patients to be treated forone year. Results will be available during 2010. Results for the primary and related renalk function endpoints from the phase II clinicalp trial evaluating bardoxolone in diabetic patients with advancecd CKD will be the subject of an oral presentatiohat 4:00 PM CDT on June 6, 2009. , , D.O., , M.D., , M.D., , M.D., Location: Morial Convention Center, New LA, Room Louisiane C Abstract No.
112-OR Results for the glycemifc control endpoints from the phase II clinicalk trial evaluating bardoxolone in diabetic patienta with advanced CKD will be the subjectf of an oral presentationat 5:15 PM CDT on June 8, 2009. Bardoxolone, a Novel Oral Anti-Inflammatorg Agent Improves Glycemic Control in Type 2 Diabetics with Chronicc KidneyDisease , M.D., , D.O., , , M.D., , M.D., Ph.D. Morial Convention Center, New LA, Hall E-2 Abstract No. 362-OR CKD is a progressive loss of kidney functio over a period of months or which can be caused by a numberof conditions, includingf diabetes and high blood pressure.
As kidne y disease gets worse, waste products can build to high levelss in the blood and patients may develop complicationd like highblood pressure, anemia (low blood count), weak bones, poor nutritionapl health and nerve damage. CKD also increases the risk of havinf heart and bloodvessel disease. As kidney disease progresses, it eventually leads to kidney failure, requiring dialysis or a kidney transplant. Reatqa Pharmaceuticals, Inc.
is a biopharmaceuticapl company focused on translating innovatives science into breakthrough medicines for intractable Reata is the leader in discovering and developing novel anti-inflammatory drugs targeting Nrf2, which controls the production of antioxidantsd and has been shown to protect againstf a broad range of diseaseds associated with inflammation and oxidative Reata is developing a portfoliok of AIMs for a variety of inflammation-relate diseases. The company's most advanced program is in late-stagew clinical development for CKD, a progressive condition affecting more than 26 million Formore information, visit . SOURCE Reata Pharmaceuticals, Inc.