TETON is a randomized, double-blind, placebo-controlled, 24-week, Phase III study in subjects with Chronic Fibrosing Interstitial Lung Disease (which includes patients with idiopathic interstitial pneumonias, chronic hypersensitivity pneumonitis, and environmental/occupational lung disease). Subjects will be randomized in a 1:1 ratio to receive inhaled treprostinil, or placebo. The primary endpoint of this study is planned to be the change from Baseline to Week 24 in absolute forced vital capacity (FVC).
The INCREASE study demonstrated improvements in parameters of lung function in patients with fibrotic lung disease (FVC and reduced exacerbations of underlying lung disease), this combined with substantial preclinical evidence of antifibrotic activity of treprostinil, are suggestive that inhaled treprostinil may offer a treatment option for patients with Fibrotic Lung Disease.
