A82-01 TETON-1 Phase 3 Clinical Trial Of Inhaled Treprostinil For The Treatment Of Idiopathic Pulmonary Fibrosis
S D Nathan, J Behr, V Cottin, P M Smith, C Deng, Y Rao, N Breytenbach, H Bell, L Peterson, K R FlahertyAbstract
Rationale
Idiopathic pulmonary fibrosis (IPF) greatly impacts quality of life and eventually leads to premature death from respiratory failure. Inhaled treprostinil was studied in IPF based upon preclinical evidence of an antifibrotic mechanism and supportive clinical observation.
Methods
TETON-1 (RIN-PF-301) was a 52-week, phase 3 study conducted in the US and Canada which enrolled participants with IPF and a forced vital capacity (FVC) ≥45% predicted. The primary endpoint was change in absolute FVC at week 52. Secondary endpoints included time to clinical worsening, time to acute exacerbation of IPF, overall survival, Kings Brief Interstitial Lung Disease Questionnaire (K-BILD), and lung diffusing capacity (DLCO).
Results
TETON-1 completed enrollment in January 2025. Headline results from the TETON-1 study are expected in the first half of 2026. Baseline characteristics of the enrolled participants are shown in Table 1 below.
Conclusions
The baseline study population of the TETON-1 study is generally comparable to other clinical studies in IPF. TETON-1 headline results are expected in the first half of 2026.
This abstract is funded by: