IRVING, Texas, June 2, 2014 – Reata Pharmaceuticals, Inc., announced that Dr. Colin Meyer, Chief Medical Officer, will present a Late-Breaking Presentation at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Congress in Amsterdam. The presentation will take place on Monday, June 2nd, at 8:00 a.m.
Dr. Meyer's presentation, titled "Investigation of Serious Adverse Events in Bardoxolone Methyl Patients in BEACON", will highlight key analyses from several studies, including the Phase 3 BEACON trial conducted in 2,185 patients with late-stage chronic kidney disease, as well as additional clinical and preclinical studies. Notably, Dr. Meyer will discuss the clinical profile, risk factors, and likely mechanistic explanation of key adverse events uncovered in the BEACON trial.
The primary finding that led to termination of BEACON was in increase in adjudicated heart failure, which occurred in 8.8% of bardoxolone methyl-treated patients and 5.0% of placebo-treated patients. The final analysis showed no significant difference in mortality. The etiology of heart failure was acute fluid overload that occurred within the first three weeks of treatment. Cardiac and renal function was not adversely affected, and no additional heart failure risk was observed after three weeks of treatment. Clinical and preclinical data suggest that bardoxolone methyl (through modulation of the endothelin pathway) acutely promoted sodium and water retention in a subset of patients with stage 4 CKD. These acute fluid retention affects were not observed in other clinical studies of healthy volunteers and stage 3 CKD patients.
Importantly, two key risk factors for development of acute fluid retention were identified: prior hospitalization for heart failure and elevated baseline B-type natriuretic peptide (BNP), a marker of fluid retention. For patients without these baseline characteristics, the risk for adjudicated heart failure events among bardoxolone methyl- and placebo- treated patients was similar (2% in each arm).
These findings suggest that bardoxolone methyl may have a favorable risk-benefit profile in patient populations that do not have the identified risk factors. Due to these findings and the strong pharmacological rationale for the use of bardoxolone methyl in patients with pulmonary arterial hypertension, bardoxolone methyl is currently being studied in a Phase 2 pulmonary arterial hypertension trial (https://clinicaltrials.gov/ct2/show/NCT02036970).
About Reata Pharmaceuticals, Inc.
Reata Pharmaceuticals, Inc. is a privately held company aiming to translate innovative research into breakthrough medicines for difficult diseases that have significant unmet needs. Reata is the leader in developing a novel class of drugs with potent transcription-regulating activity, called antioxidant inflammation modulators (AIMs). AIMs activate Nrf2, promoting the production of numerous antioxidant, detoxification, and anti-inflammatory genes, and inhibit NF-κB, a gene that regulates many pro-inflammatory proteins. The pharmacology of the AIMs mimics that of endogenous prostaglandin metabolites that are responsible for the orchestrated resolution of inflammation. The anti-inflammatory, cytoprotective and energy metabolism effects of AIM pharmacology have been documented in more than 250 scientific papers and are potentially relevant to a wide range of diseases.
Reata Pharmaceuticals, Inc.