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
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