Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study
Philip L Molyneaux1, Nikhil A Hirani2, Collin C K Chia3
1National Heart and Lung Institute, Imperial College London, London, UK.
Nature Communications
|July 31, 2026
Summary
Inhaled LTI-03 demonstrated a favorable safety profile in patients with idiopathic pulmonary fibrosis (IPF). The treatment significantly reduced key profibrotic biomarkers, supporting its potential for IPF therapy.
Area of Science:
- Pulmonology
- Pharmacology
- Biochemistry
Background:
- Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal lung disease with limited therapeutic options.
- Existing treatments offer modest benefits, highlighting the need for novel therapeutic strategies.
- LTI-03 has shown promise in preclinical models by promoting alveolar epithelial cell survival and reducing profibrotic factors.
Purpose of the Study:
- To evaluate the safety, tolerability, and preliminary efficacy of inhaled LTI-03 in participants with IPF.
- To assess the pharmacokinetic profile of inhaled LTI-03.
- To explore the impact of LTI-03 on disease-related biomarkers in IPF.
Main Methods:
- A Phase 1b, randomized, double-blind, placebo-controlled, dose-escalation study.
- 24 participants with IPF received inhaled LTI-03 (5 mg/day or 10 mg/day) or placebo for 14 days.
- Primary endpoint was treatment-emergent adverse events (TEAEs); secondary endpoints included pharmacokinetics and biomarker analysis from bronchial brushings.
Main Results:
- LTI-03 was well-tolerated with no treatment-related discontinuations or severe TEAEs.
- No evidence of airway obstruction was observed via spirometry.
- Significant reductions in interleukin-11 and thymic stromal lymphopoietin were observed in both LTI-03 groups compared to placebo.
- The 10 mg/day dose also suppressed collagen type 1 alpha chain 1, CXC chemokine ligand 7, and galectin-7.
Conclusions:
- Inhaled LTI-03 exhibits a favorable safety profile in patients with IPF.
- The observed reductions in key profibrotic biomarkers suggest a potential therapeutic benefit.
- Further investigation of inhaled LTI-03 for the treatment of IPF is warranted.
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