"Loss of kidney function is common in PAH patients and associated with an increased risk of adverse outcomes and death. Treatments for PAH improve symptoms but often worsen kidney function, placing patients at greater risk," said Daniel W. Coyne, M.D., Nephrologist and Professor of Medicine at Washington University in St. Louis, Missouri. "The two-year trial data are the longest available with bardoxolone and suggest raising kidney function with bardoxolone is not harmful and is likely to be beneficial in PAH patients and other disease states."The two-year eGFR data from LARIAT extend earlier observations that bardoxolone treatment is associated with preservation of kidney function. Recently published data from Reata's diabetic CKD trials (BEAM and BEACON) demonstrated that eGFR improvements from bardoxolone treatment were durable for at least one year and associated with a more than 50% reduced likelihood of adverse renal events validated to predict kidney failure. Most important, these data demonstrated that patients treated with bardoxolone for at least one year had a persisting improvement in kidney function versus placebo even after the drug was withdrawn for one month. This persisting increase after withdrawal suggests that the drug is improving, not harming, the structure of the kidney in humans as it does in multiple animal models of CKD. "Through these analyses of long-term clinical data, we have been able to differentiate the improvements in kidney function with bardoxolone from agents that may modestly, transiently, and adversely increase kidney function by increasing blood pressure in the kidney," said Colin Meyer, M.D., Reata's Chief Medical Officer. "The longer term data in PAH patients, who are extremely sensitive to any adverse perturbations of renal or cardiac function, provides further evidence that bardoxolone may be beneficial, and not harmful, to the kidney."
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About LARIATLARIAT is a two-part study of the efficacy and safety of bardoxolone in patients with pulmonary hypertension. Part 1 was a double-blind, randomized, placebo-controlled treatment period, and Part 2 was an open-label extension period. The study enrolled primarily WHO Group I PAH patients classified as WHO/NYHA Functional Class II and III, including those with CTD-PAH. Patients receiving one or two disease-specific PAH therapies, including endothelin receptor antagonists, riociguat, phosphodiesterase5 (PDE5) inhibitors, or prostacyclins (subcutaneous, oral, or inhaled), were eligible for enrollment. Patients from Part 1 who completed the 16-week treatment period as planned were eligible to continue directly into the extension period (Part 2) to evaluate the intermediate and long-term safety and efficacy of bardoxolone. About Bardoxolone Methyl Bardoxolone is an experimental, oral, once-daily activator of Nrf2, a transcription factor that induces molecular pathways that promote the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling. Bardoxolone is currently being studied in the Phase 3 portion of the CARDINAL trial in patients with CKD caused by Alport syndrome as well as the Phase 2 PHOENIX trial in patients with autosomal dominant polycystic kidney disease, IgA nephropathy, type 1 diabetic CKD, and focal segmental glomerulosclerosis. In addition to the CARDINAL and PHOENIX trials, bardoxolone is currently being studied in CATALYST, a Phase 3 study for the treatment of connective tissue disease associated pulmonary arterial hypertension. The FDA has granted orphan designation to bardoxolone for the treatment of Alport syndrome and the treatment of pulmonary arterial hypertension. About Reata Pharmaceuticals, Inc. Reata is a clinical-stage biopharmaceutical company that develops novel therapeutics for patients with serious or life-threatening diseases by targeting molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata's two most advanced clinical candidates, bardoxolone and omaveloxolone, target the important transcription factor Nrf2 that promotes the resolution of inflammation by restoring mitochondrial function, reducing oxidative stress, and inhibiting pro-inflammatory signaling.
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