Bardoxolone methyl (BARD) is an antioxidant inflammation modulator (AIM). It is a capsule taken by mouth, and it works differently than any of the currently approved treatments for PAH.
Research completed to date shows bardoxolone methyl:
- Increases 6 minute walk distance (6MWD) after 16 weeks of treatment in pulmonary arterial hypertension patients already receiving background therapies (based on initial data from an ongoing Phase II study)
- Improves 6MWD in pulmonary arterial hypertension patients who typically do not respond well to other therapies, including CTD-PAH patients and those with higher baseline 6MWD
- Improves mitochondrial function in animal muscle cells, which in turn may increase the cellular energy production (the body's energy level)
- Has the potential to reduce inflammation, vascular remodeling (changes in the structure of the blood vessels), and fibrosis (stiffening of the tissues), based on data from animal models
Half of the patients who participate in CATALYST will receive BARD and half will receive placebo (like a "sugar pill" containing no active drug). Whether you receive BARD or placebo is determined randomly, like by the flip of a coin.