Reata Pharmaceuticals, Inc. to Present Data from Pivotal Phase 2b Trial in Type 2 Diabetics With Chronic Kidney Disease
11/11/2010 11:27:26 AM
IRVING, Texas, Nov. 11, 2010 /PRNewswire/ -- Reata Pharmaceuticals today announced that the company will present data on the primary endpoint from a pivotal Phase 2b clinical trial of bardoxolone methyl in patients with chronic kidney disease (CKD) and type 2 diabetes. The data will be presented in a late-breaking oral presentation at the American Society of Nephrology (ASN) Renal Week Conference to be held November 16-21, 2010, in Denver, Colorado.
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, will deliver the presentation titled, "Effect of Bardoxolone Methyl on Renal Function in Patients with Chronic Kidney Disease and Type 2 Diabetes Mellitus" at 10:55 a.m. MST on Saturday, November 20, in the Wells Fargo Theater at the Denver Convention Center.
The multi-center, randomized, double-blind clinical trial enrolled 227 CKD patients 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 kidney function following 24 weeks of treatment.
ASN has not released complete abstracts for late-breaking presentations, but the title and complete list of authors of the abstract can be accessed on the ASN Web site.
In addition to the late-breaking presentation, Reata and its collaborators will present additional preclinical data from the program in poster sessions to be held between 10 a.m. and 2:30 p.m. MST on Thursday, November 18 and Friday, November 19. The titles and presenters of those posters are as follows:
"Bardoxolone methyl activates Keap1-Nrf2 and increases glutathione levels in cultured cells" by Ron Bumeister, Ph.D., Senior Scientist, Reata Pharmaceuticals
"Bardoxolone methyl improves markers of endothelial function in cultured cells" by Deborah A. Ferguson, Ph.D., Director, Discovery Biology, Reata Pharmaceuticals
"Treatment with Nrf2 activator ameliorates uremia-induced oxidative stress, endothelial dysfunction, and hypertension" by Stanislav Shelkovnikov, Ph.D., Associate Researcher, University of California, Irvine
"Treatment with an AIM increases GFR monitored by inulin clearance in rats" by W. Christian Wigley, Ph.D., Vice President, Research, Reata Pharmaceuticals
"Targeting Keap1-Nrf2 pathway ameliorates renal inflammation and fibrosis in mice with protein-overload proteinuria" by Carlamaria Zoja, Ph.D., Head, Laboratory of Experimental Models of Kidney Diseases, Mario Negri Institute for Pharmacological Research
"Effects of bardoxolone methyl on renal protein handling and secondary nephropathy" by Irina Dulubova, Ph.D., Director, Biochemistry and Structural Biology, Reata Pharmaceuticals
About Bardoxolone Methyl
Bardoxolone methyl is an antioxidant inflammation modulator (AIM) that activates Nrf2, thereby inducing the transcription of more than 250 genes that decrease the level of oxidative stress and suppress important inflammatory mediators. In two Phase 2a studies, bardoxolone methyl was shown to produce a statistically significant increase in kidney function in patients with moderate to severe CKD and Type 2 diabetes.
About Chronic Kidney Disease and Diabetic Kidney Disease (Nephropathy)
CKD is a highly prevalent condition, affecting more than 50 million adults around the world. Diabetes is the leading cause of CKD, with as many as 30 to 40 percent of Type 2 diabetics developing the disease. Available therapies modestly slow the progression of CKD, and patients ultimately progress to dialysis.
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, for the 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 Web site at www.reatapharma.com.
Contact: Heidi Chokeir, 619-528-2217, email@example.com
SOURCE Reata Pharmaceuticals