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ARTICLE | Clinical News

Bardoxolone methyl: Preliminary Phase II data

November 9, 2015 8:00 AM UTC

Preliminary data from 24 PAH patients on stable doses of background PAH therapy in the double-blind, dose-escalation, U.S. Phase II LARIAT trial showed that once-daily 2.5, 5 and 10 mg oral bardoxolone methyl led to a placebo-adjusted improvement in 6MWD of 21.4 meters from baseline to week 16 (p=0.037). Bardoxolone methyl also led to a placebo-adjusted weight loss of 3 kg at week 16. In patients with connective tissue disease associated PAH, bardoxolone methyl led to a 30 meter increase in mean 6MWD from baseline to week 16 and a placebo-corrected increase of 44 meters. Bardoxolone methyl was well tolerated with no treatment-related serious adverse events reported. All patients who complete the treatment period are eligible to receive bardoxolone methyl in an extension period. Data were presented at the American College of Chest Physicians meeting in Montreal. ...