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Related Experiment Video

Updated: Jun 26, 2026

Adoptive Transfer of IL-33-Stimulated Macrophages into Bleomycin-Induced Mouse Models to Study Their Effect on Idiopathic Pulmonary Fibrosis In Vivo
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Inhaled LTI-03 for Idiopathic Pulmonary Fibrosis: A Randomized Dose Escalation Study.

Philip L Molyneaux, Nikhil A Hirani, Collin C K Chia

    Medrxiv : the Preprint Server for Health Sciences
    |November 24, 2025
    PubMed
    Summary

    LTI-03, an inhaled therapy for idiopathic pulmonary fibrosis (IPF), demonstrated good safety and tolerability in a Phase 1b study. Biomarker analysis suggests potential antifibrotic and epithelial protective effects in IPF patients.

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    Area of Science:

    • Pulmonary Medicine
    • Pharmacology
    • Fibrosis Research

    Background:

    • Idiopathic pulmonary fibrosis (IPF) lacks effective treatments that halt disease progression.
    • Current IPF therapies often cause systemic side effects, leading to treatment discontinuation.
    • LTI-03, a novel inhaled therapeutic, targets caveolin scaffolding domain (CSD) peptide to replenish lost Cav-1 signaling, showing promise in preclinical models.

    Purpose of the Study:

    • To assess the safety and pharmacokinetics (PK) of inhaled LTI-03 in IPF patients.
    • To evaluate LTI-03's effects on disease biomarkers.
    • To explore dose-related effects of LTI-03 in IPF patients.

    Main Methods:

    • Phase 1b, randomized, controlled, dose-escalation study.
    • 24 IPF participants randomized 3:1 to inhaled LTI-03 (5 or 10 mg/day) or placebo for 14 days.
    • Primary endpoint: treatment-related adverse events (TEAEs); secondary: PK and biomarker changes in plasma, PBMCs, and DBB.

    Main Results:

    • Inhaled LTI-03 was well-tolerated, with mild-to-moderate TEAEs; no discontinuations.
    • Cough was the most frequent TEAE.
    • LTI-03 reduced expression of IL-11, CXCL7, TSLP, and Galectin-7 in deep bronchial brushings, with dose-related effects on collagen and SP-D.

    Conclusions:

    • Inhaled LTI-03 shows a favorable safety and tolerability profile in IPF patients over 14 days.
    • Biomarker data suggest positive effects on epithelial homeostasis and antifibrotic activity.
    • Results support further investigation of LTI-03 in a Phase 2 efficacy study for IPF.