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@article{Molyneaux:2026:10.1038/s41467-026-75291-3,
author = {Molyneaux, PL and Hirani, NA and Chia, CCK and Kulkarni, T and Zaman, T and Kaner, RJ and Coelho, AL and Jannini-Sa, YAP and Windsor, B and Kruger, S and Christensen, DJ and Shoemaker, SA and Hogaboam, CM and MacKenzie, B and Günther, A},
doi = {10.1038/s41467-026-75291-3},
journal = {Nat Commun},
title = {Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study.},
url = {http://dx.doi.org/10.1038/s41467-026-75291-3},
volume = {17},
year = {2026}
}
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TY  - JOUR
AB  - Idiopathic pulmonary fibrosis (IPF) is a fatal interstitial lung disease with limited treatment options. LTI-03 promotes alveolar epithelial cell survival and reduces profibrotic protein expression in experimental models of IPF. In this Phase 1b, randomized, double-blind, placebo-controlled dose-escalation study, 24 participants with IPF were randomized 3:1 to inhaled LTI-03 5 mg/day (N = 9), LTI-03 10 mg/day (N = 9) or placebo (N = 6) for 14 days and included in all analyses (ClinicalTrials.gov: NCT05954988). The primary endpoint was the incidence of treatment-emergent adverse events (TEAEs). Exploratory analyses included pharmacokinetics and disease-related biomarkers. LTI-03 was well-tolerated, with no treatment-related discontinuations, no severe TEAEs, and no evidence of airway obstruction by spirometry and associated symptoms. In deep bronchial brushings, both LTI-03 doses significantly reduced interleukin-11 (p = 0.0406 at 5 mg/day; p = 0.044 at 10 mg/day) and thymic stromal lymphopoietin (p = 0.0256 at 5 mg/day; p = 0.0128 at 10 mg/day) versus placebo. The 10 mg/day dose suppressed collagen type 1 alpha chain 1 (p = 0.0248), CXC chemokine ligand 7 (p = 0.0248) and galectin-7 (p = 0.0332). Other measured biomarkers were not significantly changed. The favorable safety profile and reductions in disease-related biomarkers support further evaluation of inhaled LTI-03 for IPF. This study was fully funded by Rein Therapeutics, Inc.
AU  - Molyneaux,PL
AU  - Hirani,NA
AU  - Chia,CCK
AU  - Kulkarni,T
AU  - Zaman,T
AU  - Kaner,RJ
AU  - Coelho,AL
AU  - Jannini-Sa,YAP
AU  - Windsor,B
AU  - Kruger,S
AU  - Christensen,DJ
AU  - Shoemaker,SA
AU  - Hogaboam,CM
AU  - MacKenzie,B
AU  - Günther,A
DO  - 10.1038/s41467-026-75291-3
PY  - 2026///
TI  - Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study.
T2  - Nat Commun
UR  - http://dx.doi.org/10.1038/s41467-026-75291-3
UR  - https://www.ncbi.nlm.nih.gov/pubmed/42538332
VL  - 17
ER  -
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