Reata Pharmaceuticals 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.
Pablo Pergola, MD, PhD, research director for Renal Associates PA and Clinical Associate Professor of Medicine at the University of Texas Health Science Centre at San Antonio, will deliver the presentation titled, “Effect of Bardoxolone methyl on renal function in patients with CKD and type 2 diabetes mellitus”.
The multi-centre, 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. In addition to the late-breaking presentation, Reata and its collaborators will present additional preclinical data from the programme in poster session.
“Bardoxolone methyl activates Keap1-Nrf2 and increases glutathione levels in cultured cells” said by Ron Bumeister, PhD, senior scientist, Reata Pharmaceuticals. “Bardoxolone methyl improves markers of endothelial function in cultured cells” added by Deborah A. Ferguson, PhD, director, discovery biology, Reata Pharmaceuticals
“Treatment with Nrf2 activator ameliorates uremia-induced oxidative stress, endothelial dysfunction, and hypertension” by Stanislav Shelkovnikov, PhD, associate researcher, University of California, Irvine
"Treatment with an AIM increases GFR monitored by insulin 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, PhD, 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, PhD, director, biochemistry and structural biology, Reata Pharmaceuticals.
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.
CKD is a highly prevalent condition, affecting more than 50 million adults around the world. Diabetes is the leading cause of it, with as many as 30 to 40 per cent of type 2 diabetics developing the disease. Available therapies modestly slow the progression and patients ultimately progress to dialysis
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.