Leramistat for Idiopathic Pulmonary Fibrosis

Recruiting at 64 trial locations

Overseen By General Information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Modern Biosciences Ltd

Must be taking: Anti-fibrotics

Disqualifiers: Emphysema, Malignancy, COPD, Asthma, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called leramistat in people aged 40 and older who have idiopathic pulmonary fibrosis (IPF). The goal is to see if leramistat can reduce lung scarring or inflammation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anti-fibrotic treatments like nintedanib or pirfenidone, you must be on a stable dose for at least 8 weeks before starting the trial.

What data supports the effectiveness of the drug MBS2320 for treating idiopathic pulmonary fibrosis?

Research on a similar compound, TS1, shows it can reverse lung fibrosis by targeting myofibroblast differentiation, which is a key process in fibrotic diseases. This suggests that MBS2320, if similar, might also be effective in treating idiopathic pulmonary fibrosis. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for adults over 40 with idiopathic pulmonary fibrosis (IPF), able to walk at least 150 meters, and on stable anti-fibrotic treatment if any. They should have a certain level of lung function and life expectancy of more than a year. Excluded are those with significant heart issues, drug allergies including to leramistat, severe emphysema or COPD, recent cancer except some skin cancers, or history of serious infections.

Inclusion Criteria

I have been diagnosed with IPF based on a detailed lung scan or biopsy.

Has a life expectancy of at least 12 months (in the opinion of the investigator)

Your lung function test shows a specific measurement that is not within the expected range.

Exclusion Criteria

I use more than two treatments regularly for my COPD or asthma.

I have COPD or asthma and needed hospital care or steroids in the last year.

I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that was treated.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 to 4 weeks

Treatment

Participants receive daily oral dosing of leramistat or placebo for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person)

Treatment Details

Interventions

• MBS2320

Trial Overview The study tests the effects of Leramistat against a placebo in treating IPF over 12 weeks. Participants will take daily oral doses to see if there's an improvement in their condition compared to those taking the non-active placebo.

Participant Groups

Group I: Leramistat Experimental Treatment 1 Intervention

Leramistat once daily

Group II: Placebo Placebo Group 1 Intervention

Placebo comparator

Who Is Running the Clinical Trial?

Modern Biosciences Ltd

Lead Sponsor

Trials

5

Recruited

670+

Findings from Research

In a phase 2 trial involving 140 patients with idiopathic pulmonary fibrosis (IPF), the LPA1 antagonist BMS-986020 significantly reduced the decline in lung function (measured by forced vital capacity) over 26 weeks compared to placebo, indicating its potential efficacy in treating IPF.

BMS-986020 treatment led to significant reductions in serum levels of extracellular matrix (ECM)-neoepitope biomarkers associated with IPF prognosis, and in vitro studies showed that it effectively inhibited LPA1-induced fibrogenesis, revealing a novel antifibrotic mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LPA1 antagonist BMS-986020 changes collagen dynamics and exerts antifibrotic effects in vitro and in patients with idiopathic pulmonary fibrosis. Decato, BE., Leeming, DJ., Sand, JMB., et al.[2022]

A systematic review of six studies showed that pirfenidone, nintedanib, and pamrevlumab are all effective in slowing the decline of forced vital capacity (FVC) in patients with idiopathic pulmonary fibrosis (IPF), with pamrevlumab showing the highest effect size.

Only pirfenidone demonstrated a significant impact on all-cause mortality, suggesting it may offer additional benefits beyond just slowing FVC decline, while pamrevlumab is emerging as a promising candidate for future treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Pirfenidone, Nintedanib, and Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis. Di Martino, E., Provenzani, A., Vitulo, P., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

LPA1 antagonist BMS-986020 changes collagen dynamics and exerts antifibrotic effects in vitro and in patients with idiopathic pulmonary fibrosis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Wet-dry-wet drug screen leads to the synthesis of TS1, a novel compound reversing lung fibrosis through inhibition of myofibroblast differentiation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Systematic Review and Meta-analysis of Pirfenidone, Nintedanib, and Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Antifibrotic therapy - new approvals for non-IPF interstitial lung diseases]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Risk of interstitial lung disease associated with EGFR-TKIs in advanced non-small-cell lung cancer: a meta-analysis of 24 phase III clinical trials. [2018]