Presentation of Results from the MOXIe Part 2 Study, by Dr. David Lynch

Part 2 of MOXIe was an international, multi-center, double-blind, placebo-controlled Phase 2 trial of omaveloxolone in patients with Friedreich’s ataxia.

Kidney Effects in the MOXIe Trial: Presentation at ERA-EDTA 2020

Friedreich’s Ataxia (FA) is a rare, progressive, and debilitating genetic disorder with no approved treatments. Kidney function was assessed in patients with Friedreich’s ataxia in Part 2 of MOXIe, a Phase 2 international, multicenter, double-blind, randomized, placebo-controlled study of omaveloxolone in FA.

Keap1/Nrf2 Pathway Regulates GFR by Increasing the Glomerular Effective Filtration Area Without Affecting the Afferent/Efferent Arteriole Ratio: Presentation at ERA-EDTA 2020

Pharmacologic and genetic investigation of the mechanisms of GFR regulation by Nrf2 using in vivo multiphoton microscope (MPM) imaging techniques.

Publication: Omaveloxolone and TX63682 Are Hepatoprotective in the STAM Mouse Model of NASH

This preclinical study evaluated the effects of omaveloxolone and TX63682, a closely related structural analog, in the STAM mouse model of nonalcoholic steatohepatitis (NASH), a progressive form of liver disease.

Publication: TSUBAKI, a Study of Bardoxolone Methyl in Patients with Diabetic CKD

TSUBAKI was a Phase 2, randomized, multicenter, double-blind, placebo-controlled study of bardoxolone methyl in patients with type 2 diabetes and stage 3-4 chronic kidney disease. The primary efficacy endpoint was change from baseline in GFR measured by inulin clearance at week 16.

Data Presentation: Topline Results from Year One of the CARDINAL Study of Bardoxolone Methyl in Alport Syndrome

The Phase 3 portion of CARDINAL is an international, multi-center, double-blind, placebo-controlled, randomized trial that enrolled 157 patients with chronic kidney disease caused by Alport syndrome. The primary endpoint for the study was the change in estimated glomerular filtration rate (eGFR) after 48 weeks of treatment. The key secondary endpoint for the study was the change in the off-treatment eGFR after 48 weeks of treatment and four weeks of drug withdrawal.

Data Presentation: Topline Data from Part 2 of the MOXIe Trial of Omaveloxolone in Patients with Friedreich’s Ataxia

Part 2 of MOXIe was a Phase 2 international, multicenter, double-blind, randomized, and placebo-controlled study in patients with Friedreich’s ataxia, a rare, progressive, and debilitating genetic disorder with no approved treatments.

Publication: Bardoxolone Methyl Analog Attenuates Proteinuria-Induced Tubular Damage by Modulating Mitochondrial Function

The effects of dihydro‐CDDO‐trifluoroethyl amide (dh404), a rodent‐tolerable bardoxolone methyl analog, on the tubulointerstitium, were tested in an Institute of Cancer Research‐derived glomerulonephritis (ICGN) mouse model of kidney disease. The effect of dh404 on mitochondrial function, was assessed using human proximal tubular cells in vitro.

Publication: Effect of Bardoxolone Methyl on the Urine Albumin-To-Creatinine Ratio in Patients With Type 2 Diabetes and Stage 4 Chronic Kidney Disease

Post-hoc analyses to characterize the relationship between the urine albumin-to-creatinine ratio and estimated glomerular filtration rate in response to bardoxolone methyl treatment in BEACON, a Phase 3 placebo-controlled, randomized, double-blind, parallel-group, international, multicenter trial of bardoxolone methyl in 2,185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease.

Analyses from a Phase 2 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD): The PHOENIX Study: Presentation at ASN KidneyWeek 2018

PHOENIX was a Phase 2, open-label, multi-center, US-only trial of bardoxolone methyl in four separate cohorts of patients with autosomal dominant polycystic kidney disease, IgA nephropathy, type 1 diabetic chronic kidney disease, or focal segmental glomerulosclerosis. The trial enrolled 31 patients with autosomal dominant polycystic kidney disease and the primary endpoint was change in estimated glomerular filtration rate at Week 12.

Analyses from a Phase 2 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with IgA Nephropathy: The PHOENIX Study: Presentation at ASN Kidney Week 2018

PHOENIX was a Phase 2, open-label, multi-center, US-only trial of bardoxolone methyl in four separate cohorts of patients with autosomal dominant polycystic kidney disease, IgA nephropathy, type 1 diabetic chronic kidney disease, or focal segmental glomerulosclerosis. The trial enrolled 26 patients with IgA nephropathy and the primary endpoint was change in estimated glomerular filtration rate at Week 12.

Analyses from a Phase 2 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Type 1 Diabetes (T1D CKD): The PHOENIX Study: Presentation at ASN KidneyWeek 2018

PHOENIX was a Phase 2, open-label, multi-center, US-only trial of bardoxolone methyl in four separate cohorts of patients with autosomal dominant polycystic kidney disease, IgA nephropathy, type 1 diabetic chronic kidney disease, or focal segmental glomerulosclerosis. The trial enrolled 28 patients with type 1 diabetic chronic kidney disease and the primary endpoint was change in estimated glomerular filtration rate at Week 12.

Publication: Effects of Bardoxolone Methyl on Body Weight, Waist Circumference and Glycemic Control in Obese Patients with T2DM and Stage 4 Chronic Kidney Disease

Post-hoc analyses to characterize changes in body weight in response to bardoxolone methyl treatment in BEACON, a Phase 3 placebo-controlled, randomized, double-blind, parallel-group, international, multicenter trial of bardoxolone methyl in 2,185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease.

Data Presentation: Reata Announces Improvements in Kidney Function with Bardoxolone Methyl Maintained for Two Years in PAH Patients from LARIAT Trial

Reata announced results from the long-term follow up portion of the LARIAT study demonstrating that pulmonary arterial hypertension patients treated with bardoxolone methyl experienced kidney function improvements that were durable for two years and not associated with adverse outcomes.

Publication: Post-Hoc Analyses from Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes Study

Post-hoc analyses to characterize changes in kidney function in response to bardoxolone methyl treatment in BEACON, a Phase 3 placebo-controlled, randomized, double-blind, parallel-group, international, multicenter trial of bardoxolone methyl in 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease.

Publication: Bardoxolone Methyl Decreases Megalin and Activates Nrf2 in the Kidney

A preclinical investigation on the role of megalin, a protein involved in the tubular reabsorption of albumin and lipid-bound proteins, in changes in albuminuria in animals treated with bardoxolone methyl.