TETON phase 3 clinical trials of inhaled treprostinil in the treatment of idiopathic pulmonary fibrosis

RATIONALE: Idiopathic pulmonary fibrosis (IPF) greatly impacts quality of life and eventually leads to premature death from respiratory failure. Inhaled treprostinil demonstrated improvements in a post hoc analysis of the INCREASE trial in patients with pulmonary hypertension associated with interstitial lung disease. These results, combined with preclinical evidence of treprostinil’s antifibrotic activity, support its investigation in the treatment of IPF. METHODS: The TETON program consists of two replicate, 52-week, phase 3 studies. Each study enrolled subjects with a diagnosis of IPF and a forced vital capacity (FVC) ≥45% predicted. The primary endpoint is change in absolute FVC at week 52. Key secondary endpoints include time to clinical worsening, time to acute exacerbation of IPF and overall survival. RESULTS: Both trials have been fully enrolled, with TETON-2 completing enrollment in July 2024 and TETON-1 completing enrollment in January 2025. Table 1. Preliminary Baseline Characteristics of Subjects Enrolled in TETON-1 and TETON-2 erj;66/suppl_69/OA1254/F1F1F1 CONCLUSIONS: The baseline study populations of the placebo-controlled, Phase 3 TETON IPF clinical trials are generally comparable to other recent trials. Headline results are expected in the second half of 2025 for the TETON-2 trial and in the first half of 2026 for the TETON-1 trial.