United Therapeutics has announced the initiation of the Phase 3 TETON 2 trial of Tyvaso treprostinil inhalation solution in patients with idiopathic pulmonary fibrosis (IPF). In December 2020, the company announced that the FDA had granted orphan drug designation to treprostinil for the treatment of IPF and had cleared an IND for the Phase 3 TETON program. The TETON 1 trial began in 2021.
The TETON 2 study design is basically the same as TETON 1, but the study will be conducted outside the US and CANADA. The trial is expected to enroll 396 patients will evaluate 3 inhalations of nebulized Tyvaso 4 times daily vs placebo, with each inhalation delivering an approximately 6 mcg dose; the primary endpoint is change in FVC from baseline to Week 52.
Tyvaso inhalation solution has been approved by the FDA for the treatment of pulmonary arterial hypertension since July 2009 and for the treatment of PH with interstitial lung disease (PH-ILD) since March 2021. United Therapeutics recently terminated the Phase 3 PERFECT study of Tyvaso inhalation solution in patients with PH-COPD due to issues identified by the Data Safety Monitoring Committee for that trial. Neither TETON trial is evaluating the Tyvaso DPI, which was approved by the FDA in May 2022 for the treatment of PAH and PH-ILD.
United Therapeutics VP of Global Product Development Peter Smith commented, “The expansion of the TETON program demonstrates our excitement about the potential for Tyvaso in IPF. Like with TETON 1, the TETON 2 study is an example of our flexible development model to expand beyond PH to potentially help us better understand the impact of treprostinil as a potential treatment option for this vulnerable group of patients.”
Read the United Therapeutics press release.
