United Therapeutics has finished enrolling participants for the TETON 2 study of Tyvaso (treprostinil) in treating idiopathic pulmonary fibrosis (IPF).
TETON 2 will assess the safety and efficacy of Tyvaso inhalation solution (nebulized Tyvaso) in 597 patients with IPF.
The trial is part of the global TETON clinical trial programme which includes three studies evaluating inhaled treprostinil for IPF and progressive pulmonary fibrosis (PPF).
The TETON 2 study is a Phase 3 registration trial, conducted at multiple centres outside the US and Canada.
It is a randomised, double-blind, placebo-controlled study designed to assess nebulized Tyvaso over 52 weeks. Full enrolment was achieved in July 2024, with top-line data anticipated in the second half of 2025.
Participants will be randomly assigned in a 1:1 ratio to receive either a nebulized Tyvaso or a placebo.
The primary endpoint of the study is the change in forced vital capacity (FVC) from baseline to week 52.
United Therapeutics product development vice president Peter Smith said: “On behalf of my colleagues at United Therapeutics, I’d like to thank the patients and investigators around the world for the courage and determination to participate in the potentially revolutionary TETON 2 study.
“Our continued goal with the TETON programme is to demonstrate that inhaled treprostinil can lead to better patient outcomes in this underserved, vulnerable patient population with fibrotic lung disease.”
TETON 1 focuses on IPF patients in the US and Canada, while TETON 2 assesses IPF patients outside these regions. TETON PPF evaluates PPF patients worldwide.
Participants in any TETON programme study may receive nebulized Tyvaso either as a monotherapy or in combination with one approved background therapy for IPF or PPF. Enrolment in TETON 1 and TETON PPF is currently ongoing.
The TETON programme was initiated following findings from the INCREASE study of nebulized Tyvaso for pulmonary hypertension associated with interstitial lung disease (PH-ILD).
A post-hoc analysis revealed significant improvements in the percent predicted forced vital capacity (FVC) at weeks 8 and 16.
United Therapeutics plans to pursue US Food and Drug Administration (FDA) approval to broaden the Tyvaso DPI label to encompass IPF and PPF.
