LTI-03 for Pulmonary Fibrosis

Not currently recruiting at 1 trial location

Overseen By Shawna H. Evans

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rein Therapeutics

Must be taking: Nintedanib, Pirfenidone, Nerandomilast

Must not be taking: N-acetyl cysteine, Corticosteroids

Disqualifiers: Active smoker, Renal impairment, Hepatic impairment, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new inhaler medication called LTI-03, which may benefit individuals with idiopathic pulmonary fibrosis (IPF). IPF leads to lung scarring and breathing difficulties, worsening over time. The trial will assess the safety of LTI-03 and its potential to improve lung scarring and symptoms like difficulty breathing. It targets individuals diagnosed with IPF within the last five years, particularly those stable on certain IPF medications. Participants will use an inhaler with either LTI-03 or a placebo (inactive substance) to compare effects. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications to join the trial?

If you are taking nintedanib, pirfenidone, or nerandomilast, you can continue as long as you've been on a stable dose for at least 12 weeks. If you previously took these medications, you must have stopped at least 8 weeks before joining. Other medications like N-acetyl cysteine and certain supplements should be stopped 7 days before starting the trial.

Is there any evidence suggesting that LTI-03 is likely to be safe for humans?

Research has shown that LTI-03 might be a safe treatment for people with Idiopathic Pulmonary Fibrosis (IPF). Early studies with healthy volunteers have examined how well the body handles inhaled LTI-03. These studies help determine if the treatment causes any side effects. Although detailed information on specific side effects is not yet available, ongoing research continues to monitor them.

LTI-03 targets both lung scarring and healing, and this dual action could be important for its potential benefits. The treatment is now in a Phase 2 trial, indicating that earlier trials found it generally safe enough for testing in more people.

Prospective participants should know that the trial includes regular checks on heart and lung health. These checks help monitor any side effects that might occur. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pulmonary fibrosis?

Researchers are excited about LTI-03 for pulmonary fibrosis because it targets the disease in a novel way. Unlike standard treatments like pirfenidone and nintedanib, which primarily work to slow disease progression, LTI-03 uses a Caveolin-1-Scaffolding-Protein-Derived Peptide. This approach aims to directly modify cellular processes involved in lung tissue repair and fibrosis. This new mechanism of action could provide more effective management and possibly even reverse some damage caused by the disease, offering hope for improved outcomes.

What evidence suggests that LTI-03 might be an effective treatment for pulmonary fibrosis?

Research has shown that LTI-03, the investigational treatment in this trial, may help treat idiopathic pulmonary fibrosis (IPF). Early results suggest LTI-03 could slow lung scarring and aid in lung healing by targeting a protein involved in lung damage and repair. Studies indicate that LTI-03 reduces lung scarring in laboratory tests and protects important lung cells needed for breathing. These findings suggest LTI-03 might improve lung function and symptoms in people with IPF. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) within the last 5 years. Those on a stable dose of certain IPF medications like nintedanib, pirfenidone, or nerandomilast may join. Participants must be able to attend up to 9 clinic visits and use an inhaler correctly.

Inclusion Criteria

Able to adequately self-administer study drug using the protocol-specified inhaler device

I am 40 years old or older.

Forced vital capacity (FVC) percent predicted ≥ 45%

Exclusion Criteria

My liver is not working well, with high bilirubin and low albumin levels, and my blood takes longer to clot.

Forced expiratory volume in 1 second (FEV1)/FVC < 0.7

I haven't taken N-acetyl cysteine or similar supplements in the last 7 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive LTI-03 or placebo for 24 weeks to evaluate safety, tolerability, and efficacy

24 weeks

Up to 9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LTI-03

Trial Overview The study tests LTI-03, an experimental drug delivered via inhaler aimed at treating IPF by protecting lung cells and reducing scarring. It's compared against a placebo over a 24-week period with additional follow-up, involving physical exams, heart monitoring, blood tests for safety and disease markers, lung function tests, questionnaires about symptoms and specialized lung scans.

How Is the Trial Designed?

Group I: (2) 2.5 mg LTI-03 capsules BID Experimental Treatment 2 Interventions

Caveolin-1-Scaffolding-Protein-Derived Peptide

Group II: (1) 2.5 mg LTI-03 capsule BID Experimental Treatment 2 Interventions

Caveolin-1-Scaffolding-Protein-Derived Peptide

Group III: (2) Placebo capsules BID Placebo Group 2 Interventions

Lactose powder

Group IV: (1) Placebo capsule BID Placebo Group 2 Interventions

Lactose powder

Who Is Running the Clinical Trial?

Rein Therapeutics

Lead Sponsor

Citations

1. ir.reintx.com ir.reintx.com/news-releases/news-release-details/rein-therapeutics-announces-new-scientific-publication

Release Details Early data suggests that LTI-03 may represent a dual-acting approach: slowing fibrosis and promoting lung healing. About Idiopathic Pulmonary ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06968845

A Phase 2 Study of LTI-03 in Patients With Idiopathic ... As the disease progresses, patients experience loss of lung function and increased breathing problems. LTI-03 is hypothesized to treat IPF by protecting and ...

3. investors.aileronrx.com investors.aileronrx.com/news-releases/news-release-details/aileron-therapeutics-announces-positive-topline-data-cohort-2

Aileron Therapeutics Announces Positive Topline Data ... LTI-03 is a novel, Caveolin-1-related peptide that modulates both pro-fibrotic activity and sustain critical alveolar epithelial cells.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12496166/

LTI-03 peptide demonstrates anti-fibrotic activity in ex vivo ... Antifibrotic drug candidates are routinely evaluated in the rodent bleomycin model of lung fibrosis for their ability to reduce extracellular matrix (ECM) ...

5. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A4651

American Journal of Respiratory and Critical Care Medicine This study aimed to characterize progressive fibrotic activity in IPF PCLS explants and to evaluate the antifibrotic effects of LTI-03 and nintedanib in this ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04233814

Safety, Tolerability and Pharmacokinetic Study of LTI-03 in ... The current study will investigate the initial safety, tolerability, and PK profile of inhaled LTI-03 in healthy volunteers. In order to minimize exposure, ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38712072/

Pre-clinical proof-of-concept of anti-fibrotic activity of caveolin ... This study aimed to characterize progressive fibrotic activity in IPF PCLS explants and to evaluate the antifibrotic effects of LTI-03 and nintedanib in this ...

8. cell.com cell.com/iscience/fulltext/S2589-0042(25)01698-0

LTI-03 peptide demonstrates anti-fibrotic activity in ex vivo ... IPF is characterized by progressive interstitial fibrosis of the lung parenchyma, which results in continuous loss of lung function and gas exchange properties.