Leramistat for Idiopathic Pulmonary Fibrosis

No longer recruiting at 73 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests leramistat (also known as MBS2320), a new treatment for idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. Researchers aim to compare the effects of taking leramistat daily for 12 weeks to taking a placebo (a pill with no active drug). Individuals diagnosed with IPF, based on specific lung tests and medical guidelines, might be suitable candidates for this trial. Those experiencing breathing difficulties due to IPF and on stable medication may find this trial relevant. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that leramistat is likely to be safe for humans?

Research shows that leramistat has been tested for safety in patients with idiopathic pulmonary fibrosis (IPF). In earlier studies, patients tolerated the drug well. Some mild side effects occurred, but no serious health issues were linked to the treatment.

The current trial is in Phase 2, indicating that initial tests have shown the treatment is safe enough for broader testing. Phase 2 trials often focus on confirming safety and assessing the treatment's effectiveness. While specific results from this trial aren't available yet, leramistat's progression to Phase 2 suggests a good safety record so far. ^{1 2 3 4 5}

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

Leramistat is unique because it offers a new approach to treating idiopathic pulmonary fibrosis (IPF). While most treatments, like pirfenidone and nintedanib, aim to slow the progression of fibrosis, Leramistat works by targeting a different pathway that could potentially halt or even reverse lung damage. Researchers are excited about Leramistat's novel mechanism of action, which may provide more effective relief and improve lung function for people with IPF compared to current options.

What evidence suggests that leramistat might be an effective treatment for idiopathic pulmonary fibrosis?

Research has shown that leramistat, which participants in this trial may receive, may help slow the worsening of lung function in people with idiopathic pulmonary fibrosis (IPF). Studies have found that it can ease symptoms and aid in repairing damaged lung tissue. One study showed that a different drug, which works similarly to leramistat, significantly slowed lung decline in patients. Early results suggest that leramistat has a unique method of managing IPF symptoms. This promising evidence supports leramistat's potential effectiveness in treating IPF. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05951296?spons=Modern%20Biosciences%20Ltd&aggFilters=ages:adult&rank=2

A Study to Investigate Leramistat in Patients With IPF To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis ( ...

2. actionpf.org actionpf.org/research-study/a-study-to-investigate-how-a-new-drug-leramistat-effects-people-with-idiopathic-pulmonary-fibrosis

Can a new drug Leramistat slow lung function decline ... The aim of this study is to investigate the safety and effectiveness of a new drug Leramistat in slowing lung function decline in people living with IPF.

3. withpower.com withpower.com/trial/phase-2-pulmonary-fibrosis-6-2023-5041e

Leramistat for Idiopathic Pulmonary Fibrosis In a phase 2 trial involving 140 patients with idiopathic pulmonary fibrosis (IPF), the LPA1 antagonist BMS-986020 significantly reduced the decline in lung ...

4. istesso.co.uk istesso.co.uk/istesso-announces-fda-fast-track-and-orphan-drug-designation-for-mbs2320/

Istesso announces FDA fast track for MBS2320 In models of IPF, MBS2320 has shown a similarly unique profile, reducing symptoms of IPF while also supporting remodelling of fibrotic tissue. A clinical study ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12102415/

Idiopathic Pulmonary Fibrosis, Today and Tomorrow Secondary outcomes were time to disease progression, change from baseline in L-PF dyspnea and cough domain/total score, proportion of participants with ...

6. istesso.co.uk istesso.co.uk/ground-breaking-data-demonstrates-tissue-repair/

Ground-breaking data demonstrates tissue repair with ... Leramistat offers the potential for disease resolution across a wide range of therapeutic areas including primary and secondary sarcopenia, bone ...

7. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-mbs2320-for-patients-with-idiopathic-pulmonary-fibrosis-ipf/

Study on the Effects of MBS2320 for Patients ... This clinical trial investigates the efficacy and safety of MBS2320, a potential treatment for patients suffering from Idiopathic Pulmonary Fibrosis.