Evidence map›Paper›PMID 42538332›Full record

Trial reportNature communications2026

Inhaled LTI-03 for idiopathic pulmonary fibrosis: a randomized dose escalation study.

Philip L Molyneaux, Nikhil A Hirani, Collin C K Chia, Tejaswini Kulkarni, Tanzira Zaman, Robert J Kaner, Ana Lucia Coelho, Yago Amigo Pinho Jannini-Sa, Brian Windsor, Sydney Kruger and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05954988 (A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacodynamic Biomarker Study of Caveolin-1-Scaffolding-Protein-Derived Peptide), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05954988 phase1completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacodynamic Biomarker Study of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Recently Diagnosed, Treatment Naïve Subjects With IPF

TypeinterventionalSponsorRein TherapeuticsRan2023 to 2024Enrolled24ConditionsIdiopathic Pulmonary FibrosisArmsLTI-03, Placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Philip L MolyneauxNational Heart and Lung Institute, Imperial College London, London, UK.ORCID 0000-0003-1301-8800
Nikhil A HiraniInstitute for Regeneration and Repair, University of Edinburgh, Edinburgh, UK.ORCID 0000-0001-8854-3605
Collin C K ChiaLaunceston Respiratory and Sleep Center, Launceston General Hospital, Launceston, TAS, Australia.
Tejaswini KulkarniPulmonary, Allergy & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.ORCID 0000-0002-4251-4988
Tanzira ZamanPulmonary & Critical Care Medicine, Cedars Sinai Medical Center, Los Angeles, CA, USA.
Robert J KanerWeill Cornell Medicine, New York, NY, USA.
Ana Lucia CoelhoWomen's Guild Lung Institute, Cedars Sinai Medical Center, Los Angeles, CA, USA.
Yago Amigo Pinho Jannini-SaWomen's Guild Lung Institute, Cedars Sinai Medical Center, Los Angeles, CA, USA.
Brian WindsorRein Therapeutics, Inc., Austin, TX, USA.
Sydney KrugerRein Therapeutics, Inc., Austin, TX, USA.
Dale J ChristensenDepartment of Medicine, Duke University School of Medicine, Durham, NC, USA.
Steven A ShoemakerRein Therapeutics, Inc., Austin, TX, USA.
Cory M HogaboamWomen's Guild Lung Institute, Cedars Sinai Medical Center, Los Angeles, CA, USA.
BreAnne MacKenzieRein Therapeutics, Inc., Austin, TX, USA.
Andreas GüntherCenter for Interstitial and Rare Lung Diseases, Justus-Liebig-University, University of Giessen and Marburg Lung Center, Member of the German Center for Lung Research, Giessen, Germany. andreas.guenther@innere.med.uni-giessen.de.ORCID 0000-0002-2187-0975

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Idiopathic Pulmonary FibrosisAdministration, InhalationAgedBiomarkersCytokinesDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansInterleukin-11MaleMiddle AgedThymic Stromal LymphopoietinTreatment OutcomeBiomarkersCytokinesInterleukin-11Thymic Stromal Lymphopoietin

Identifiers

PMID42538332
PMCPMC13427755

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.