RT Journal Article
SR Electronic
T1 LTI-201: Evaluation of the hemodynamics and safety of inhaled LIQ861 (treprostinil) in pulmonary arterial hypertension (WHO Group 1) patients
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1459
DO 10.1183/13993003.congress-2020.1459
VO 56
IS suppl 64
A1 Robert F. Roscigno
A1 Marc Humbert
A1 Toby Vaughn
A1 Werner Seeger
A1 Laurent Savale
YR 2020
UL http://erj.ersjournals.com/content/56/suppl_64/1459.abstract
AB Introduction: LIQ861 is a novel, dry-powder formulation of treprostinil (TRE) designed with PRINT® technology to enhance deep-lung drug deposition and enable delivery of TRE in 1-2 breaths per capsule 4 times per day (QID) with a convenient dry-powder inhaler (DPI).Aims and Objectives: Study aims are to characterize hemodynamic dose-response relationships for LIQ861 and to evaluate the safety of LIQ861 in patients with pulmonary arterial hypertension (PAH).Methods: LTI-201 is a European open-label, phase 2 study with a dose-escalation phase (Part A) and 16 weeks of continuous administration of LIQ861 (Part B). Eligibility criteria include New York Heart Association functional class II-IV; six-minute walk distance ≥150 m; forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) ≥60% of predicted values; and FEV1/FVC ratio ≥60%. Planned enrollment is 32 patients at 2 centers. During Part A, 4 successive cohorts (n=8 each) will receive LIQ861 in a 25, 50, 75, and 100 µg capsule-strength dose using the Plastiape RS00 Model 8 DPI device. Safety results will be reviewed before proceeding to the next dose. During Part B, PAH patients will receive LIQ861 from Day 1 through Week 16.Results: The primary efficacy endpoint is the change in pulmonary vascular resistance from baseline to maximal response on Day 1 (Part A) and Week 16 (Part B). Additional hemodynamic endpoints and pharmacokinetic parameters will be assessed during Parts A and B. The primary safety endpoint is the incidence of adverse events and SAEs in Parts A and B.Conclusion: LTI-201 will assess the pharmacokinetics, safety, and efficacy of LIQ861 in PAH patients.FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 1459.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).