United Therapeutics has completed enrolment for its TETON-PPF study, assessing the safety and efficacy of the Tyvaso (treprostinil) inhalation solution (nebulised Tyvaso) to treat progressive pulmonary fibrosis (PPF).
The randomised, multinational, placebo-controlled, double-blind Phase III registration study has enrolled a total of 754 participants.
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It will follow participants for 52 weeks, with top line results expected in the second half of 2027.
The TETON-PPF study randomised subjects in a 1:1 ratio to receive either nebulised Tyvaso or a placebo.
All participants started treatment at three breaths four times daily, with the dose titrated up to a target of 12 breaths four times daily or the maximum tolerated dose. The primary endpoint is the change in forced vital capacity from baseline to week 52.
Secondary measures include time to first clinical worsening, incidence of acute exacerbations of interstitial lung disease, 52-week overall survival, and change in several lung function and quality-of-life parameters.
Safety will be monitored by tracking adverse events, vital signs, and laboratory data. Upon completion, participants may have the chance to enter an open-label extension study.
United Therapeutics product development senior vice-president and TETON programme global lead Peter Smith said: “The rapid pace of enrolment underscores both the significant unmet need for new treatment options in PPF and the strong interest in nebulised Tyvaso’s potential in addressing the burden of this disease, particularly following the highly successful results observed in our TETON-1 and TETON-2 studies in idiopathic pulmonary fibrosis (IPF).
“We are deeply grateful to the participants, investigators, and study teams whose commitment made this milestone possible.”
If successful, United Therapeutics plans to use data from TETON-PPF to support a supplemental new drug application to the US Food and Drug Administration (FDA) to seek approval of Tyvaso for PPF, for which it is not currently approved but remains investigational.
The company is also seeking priority review of a similar application for the treatment of IPF with nebulised Tyvaso.
In July 2024, United Therapeutics completed enrolment for the TETON 2 study of Tyvaso to treat IPF.
