A Phase 2 Study of the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Patients With Pulmonary Hypertension Associated With Interstitial Lung Disease.

Colin Church¹, Maria Molina-Molina², Miguel Arias-Guillén³, Patrick Muchmore⁴, Ben R Lavon⁴, Jan De Backer⁴, Natalya Makulova⁵, Bipin Mistry⁵, Jia Guo⁵, Jasmanda Wu⁵, Junaideen Fahumy⁵, Ariel Teper⁵, Peng-Liang Zhao⁵, Kevin C Mange⁵, Gerald O'Brien⁵

¹Golden Jubilee National University Hospital and University of Glasgow Glasgow UK.

²Interstitial Lung Disease Unit, Respiratory Department, Research Lab 4126, IDIBELL, UB University Hospital of Bellvitge Barcelona Spain.

³Respiratory Department, Central University Hospital of Asturias University of Oviedo School of Medicine, ISPA; CIBERES (ISCIII) Oviedo Spain.

⁴FLUIDDA, Inc. New York New York USA.

⁵Insmed Incorporated, Bridgewater New Jersey USA.

PubMed PMC DOI PDF

Abstract

Treprostinil palmitil (TP) inhalation powder (TPIP), an investigational formulation of the treprostinil prodrug TP, was designed to provide prolonged pulmonary vasodilation with once-daily administration. In this phase 2 study (NCT05176951), adults with pulmonary hypertension associated with interstitial lung disease (PH-ILD) were randomized 3:1 to receive TPIP (n = 29) or placebo (n = 10) for 16…

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