Reata Pharmaceuticals’ bardoxolone methyl significantly improved the exercise capacity of patients with idiopathic lung disease (ILD) associated with pulmonary hypertension (PH), a Phase 2 clinical trial showed.
The ongoing LARIAT study (NCT02036970) is evaluating the safety and efficacy of bardoxolone in about 165 patients whose PH is associated with several lung diseases. They include idiopathic pulmonary fibrosis (IPF), sarcoidosis, connective tissue disorder, and idiopathic interstitial pneumonia.
The latest results covered eight patients with IPF and 25 with sarcoidosis. All were treated with bardoxolone or a placebo.
After 16 weeks of bardoxolone, the IPF patients were able to walk 38 meters further than before treatment in an exercise-capacity assessment known as the six-minute walking distance (6MWD) test. In contrast, placebo-treated patients were able to walk 13 fewer meters.
Sarcoidosis patients were able to walk 17 meters more by week 16, compared with an increase of nine meters in the placebo group that was not considered statistically significant.
Researchers said bardoxolone was safe, and patients tolerated it well, with no new safety issues reported.
The findings suggested that bardoxolone has the potential to improve IPF and sarcoidosis patients’ ability to perform daily tasks, which for many becomes a challenge as the disease progresses.
“We are encouraged by these initial results, especially those in IPF patients, and they support our ongoing efforts in pulmonary hypertension,” Dr. Colin Meyer, the chief medical officer of Reata, said in a press release.
Bardoxolone methyl belongs to a class of small molecules that target an important regulator of cell response called Nrf2. The drug is designed to activate Nrf2, regulating several signaling cascades involved in oxidative damage, inflammation, and fibrosis.
Bardoxolone has received orphan drug designations from the U.S. Food and Drug Administration as a treatment for PAH and Alport syndrome.
Previous results showed that the drug led to meaningful improvements in 6MWD in patients with connective tissue disease associated with PAH (CTD-PAH).
“The magnitude in six-minute walk distance increases observed in IPF patients is as large as the increases we observed in CTD-PAH patients in our Phase 2 LARIAT study,” Meyer said. “Once we complete our other ongoing Phase 2 trials, we will evaluate all available data from our mid-stage trials to determine prioritization and timing for this and our other programs.”