Benzinga | Oct 21, 2021 12:11PM EDT

United Therapeutics Details New Data Presented At CHEST Annual Meeting 2021

United Therapeutics Corporation (NASDAQ:UTHR), a public benefit corporation with a purpose to provide a brighter future for patients, today detailed the new clinical and real-world evidence on pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) presented at CHEST 2021, the annual meeting of the American College of Chest Physicians. United Therapeutics and its collaborators presented 10 abstracts across a broad range of studies in PAH and PH-ILD, including pharmacokinetic (PK) data from the BREEZE study of Tyvaso DPI(tm).

"Late last month we officially converted to a public benefit corporation, so now more than ever, our new research underscores our foundational DNA: the mission to improve patients' health and support healthy communities," said Andrew Nelsen, PharmD, United Therapeutics' Vice President, Global Medical Affairs. "Together with our collaborators, we are pleased to share new data derived from the BREEZE study of Tyvaso DPI, the INCREASE study of Tyvaso(r) in PH-ILD, as well as assessment of the real-world use of Orenitram(r) and Remodulin(r) at the annual CHEST 2021 meeting."

Tyvaso DPI BREEZE pharmacokinetic data demonstrate similar exposure as Tyvaso

The CHEST meeting featured a poster detailing data from the BREEZE study of Tyvaso DPI in patients with PAH. New PK data presented at CHEST 2021 demonstrated that systemic exposure between Tyvaso DPI and Tyvaso was similar; in addition, lower variability in PK parameters were observed in Tyvaso DPI when compared with Tyvaso. PK data from a separate healthy volunteer study of Tyvaso DPI will be presented at a future scientific forum.

The BREEZE study enrolled 51 subjects on a stable regimen of Tyvaso who were transitioned to Tyvaso DPI at a corresponding treprostinil dose. The primary objective of the study was to evaluate the safety and tolerability of Tyvaso DPI during a three-week treatment phase in PAH patients previously treated with Tyvaso Inhalation Solution. Secondary objectives of the study included changes in six-minute walk distance (6WMD), device preference and satisfaction as evaluated through the Preference Questionnaire for Inhaled Treprostinil Devices, and patient-reported PAH symptoms and impact. Top line data showing the BREEZE study met its primary objective were released in January 2021, and detailed data on the primary and secondary objectives were presented in September 2021.