The increase in six minute walk distance (“6MWD”) through 16 weeks of treatment that was previously reported was sustained through 32 weeks of treatment and was not significantly different from that at week 16 in the same set of patients. Bardoxolone methyl-treated patients with connective tissue disease (“CTD”)-associated PAH had similar sustained increases in 6MWD through week 32. Bardoxolone methyl was well-tolerated, and fewer adverse events were reported during the extension study than during the first 16 weeks of treatment.
"We are pleased that the interim data demonstrate that the clinically meaningful improvements in 6MWD noted through 16 weeks of treatment are sustained through 32 weeks of treatment," said
About Bardoxolone Methyl
Bardoxolone methyl is an experimental, oral once-daily antioxidant inflammation modulator (“AIM”) that has received orphan drug designation for the treatment of PAH by the
About the LARIAT Study
LARIAT (A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Pulmonary Hypertension) is a Phase 2 dose-ranging study examining the safety, tolerability, and efficacy of bardoxolone methyl in patients with PAH on stable background therapy. To determine if bardoxolone methyl could complement approved PAH therapies, the Phase 2 study was designed to assess efficacy through exercise capacity.
Patients were randomized 1:3 to receive once-daily placebo or bardoxolone methyl for 16 weeks. Patients were required to be stable on at least one approved PAH therapy. The primary efficacy variable, 6MWD, was collected at baseline and at every 4 weeks. Patients who completed the 16 week treatment period were allowed to enter an open-label, long-term extension phase of the study.
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (“PAH”) is a life-threatening disease involving chronic fatigue, endothelial dysfunction, vasoconstriction in small pulmonary arteries, dysregulated proliferation of certain vascular cells, and dysregulated pro-inflammatory signaling leading to vascular remodeling, pulmonary fibrosis, and right ventricular hypertrophy. PAH affects an estimated 15,000-20,000 people in
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