First IPF Patient Enrolled in Phase 3 Study of Tyvaso
The first participant has been enrolled in a Phase 3 trial to evaluate the impact of United Therapeutics’ Tyvaso (inhaled treprostinil) on lung function in adults with idiopathic pulmonary fibrosis (IPF).
The trial, TETON (NCT04708782), aims to recruit approximately 396 people ages 40 and older, who will undergo treatment for one year, followed by an approximately two-year open-label extension study (NCT04905693).
“Despite the availability of two approved products in the therapeutic category, there remains a critical unmet need in IPF,” Steven Nathan, MD, chair of the trial’s steering committee, said in a press release.
Volunteers in the study will receive either Tyvaso or a placebo four times daily, via a nebulizer that delivers approximately 6 micrograms of the medication per breath directly to the lungs. Participants will start treatment by receiving three breaths per session, which will be increased slowly to the target of 12 breaths per session, or until the maximum clinically tolerated dose is reached.
The trial’s main goal is to evaluate changes in patients’ lung function, as measured by forced vital capacity (FVC), a standard lung function parameter that measures how much air a person can forcefully exhale after a deep breath.
Secondary goals include monitoring the time to an individual’s clinical worsening, the time to their first IPF exacerbation (sudden symptom worsening), and overall survival during the one-year treatment period.
TETON follows a Phase 2/3 trial, called INCREASE (NCT02630316), which demonstrated that Tyvaso was able to lower the occurrence of exacerbations and prevent lung function decline in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), an umbrella term for fibrotic lung conditions that also includes IPF.
“We were pleasantly surprised to note the intriguing post-hoc analysis of safety data collected from the INCREASE study that showed a positive impact of inhaled treprostinil on FVC in IPF patients with pulmonary hypertension,” said Nathan, who also is medical director of the Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital in Falls Church, Virginia.
“In follow-up to this, the TETON study has been designed to validate the potential anti-fibrotic effects of inhaled treprostinil in IPF patients,” he added.
Tyvaso’s active ingredient, trepostinil, is a vasodilator agent that is able to lower blood pressure by relaxing and widening blood vessels in the lungs.
Last year, the U.S. Food and Drug Administration named Tyvaso an orphan drug for the treatment of IPF. More recently, the U.S. agency approved Tyvaso as the first treatment to improve exercise ability in people with PH-ILD.
Tyvaso is not yet approved for use in IPF patients without documented pulmonary hypertension (PH), a condition that causes blood pressure to rise to abnormally high levels in lung blood vessels.
“The initiation of the TETON study is an important milestone in potentially bringing an improved treatment option to patients with IPF,” said Leigh Peterson, PhD, United Therapeutics’ senior vice president of global product development.
“The TETON study is an example of our company’s flexible development model to expand beyond PH and will help us to better understand the impact of treprostinil in mitigating the FVC decline seen in IPF patients,” Peterson added.