United Therapeutics has announced the initiation of the 52-week TETON PPF trial, which will evaluate the efficacy of Tyvaso treprostinil inhalation solution in almost 700 patients with progressive pulmonary fibrosis (PPF). The company said that the effort to expand the use of Tyvaso to patients with PPF with or without pulmonary hypertension (PH) is based on data from the Phase 3 INCREASE trial of the inhalation solution in patients with PH with interstitial lung disease (PH-ILD). The FDA approved Tyvaso inhalation solution for the treatment of pulmonary arterial hypertension in July 2009 and for the treatment of PH-ILD in March 2021.
The TETON PPF trial is the third study in the Phase 3 TETON program. The TETON 1 trial of nebulized Tyvaso in patients with idiopathic pulmonary fibrosis (IPF) began in 2021 and is ongoing. Initiation of the TETON 2 trial of Tyvaso inhalation solution in IPF patients was announced in November 2022, and that trial is also ongoing.
According to United Therapeutics, the company plans to use data from the TETON program in addition to bridging studies to support an expansion of the use of Tyvaso treprostinil DPI to IPF and PPF as well, although the TETON studies do not include evaluation of the dry powder formulation. Tyvaso DPI was approved by the FDA for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) in May 2022.
United Therapeutics Associate Director, Global Product Development, Natalie Breytenbach commented, “The initiation of the global TETON PPF study illustrates confidence in nebulized Tyvaso as a potential treatment option for patients with fibrotic lung disease. The expansion of TETON into the PPF patient population allows us to continue to evaluate inhaled treprostinil’s potential for treating this vulnerable group of patients in a robust global pivotal study.”
Read the United Therapeutics press release.
