DWN12088 for Idiopathic Pulmonary Fibrosis

Recruiting at 30 trial locations

Overseen By YeaRa Kwak

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Daewoong Pharmaceutical Co. LTD.

Must be taking: Pirfenidone, Nintedanib

Must not be taking: Investigational drugs

Disqualifiers: Acute IPF exacerbation, Smoking, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

102 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called DWN12088 to see if it can help people with Idiopathic Pulmonary Fibrosis, a serious lung disease. The study will check if the drug is safe and effective. The exact way the drug works is not detailed, but it aims to improve lung function or slow down the disease.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking pirfenidone or nintedanib for IPF, you must have been on a stable dose for at least 3 months before joining the trial.

What data supports the effectiveness of the drug DWN12088 for treating idiopathic pulmonary fibrosis?

Bersiporocin, a component of DWN12088, has shown an antifibrotic effect by reducing collagen production in pulmonary fibrosis models, suggesting potential benefits for idiopathic pulmonary fibrosis. Additionally, pirfenidone, another antifibrotic drug, has been effective in slowing lung function decline in similar conditions, indicating that DWN12088 might have similar effects. ^{1 2 3 4 5}

Research Team

Song

Principal Investigator

AIDS Malignancy Consortium

Eligibility Criteria

This trial is for adults aged 40 or older with Idiopathic Pulmonary Fibrosis (IPF), having specific lung function levels. They must be stable, not have used experimental IPF drugs recently, and non-smokers for at least 3 months. Pregnant or nursing women and those with recent acute IPF exacerbations cannot participate.

Inclusion Criteria

My health is stable enough for me to join a study, based on recent medical checks.

I have been on a stable dose of IPF treatment for 3 months or have not taken any.

Your lung function test result shows that the amount of oxygen your lungs can transfer to your blood is between 25% and 80% of what is expected.

Exclusion Criteria

I am not pregnant or nursing.

Use of any investigational drugs for IPF within 4 weeks prior to screening

Your heart's electrical activity is not normal as shown by an ECG test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DWN12088 or placebo for 24 weeks to evaluate safety and efficacy

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DWN12088
• Placebo

Trial Overview The study tests DWN12088's safety and effectiveness against a placebo in managing IPF. Participants are randomly assigned to receive either the drug or a placebo without knowing which one they get, ensuring the results are unbiased.

Participant Groups

Group I: DWN12088 Xmg Tablet (BID) Experimental Treatment 1 Intervention

PRS inhibitor

Group II: Placebo 0mg Tablet (BID) Placebo Group 1 Intervention

Placebo

DWN12088 is already approved in European Union, United States for the following indications:

Approved in European Union as Bersiporocin for:

• Idiopathic Pulmonary Fibrosis (Orphan Drug Designation)

Approved in United States as Bersiporocin for:

• Idiopathic Pulmonary Fibrosis (Fast Track Designation)

Who Is Running the Clinical Trial?

Daewoong Pharmaceutical Co. LTD.

Lead Sponsor

Trials

209

Recruited

156,000+

Park Sung-soo

Daewoong Pharmaceutical Co. LTD.

Chief Executive Officer since 2024

Master's degree in Medicinal Chemistry from Seoul National University

Lee Chang-jae

Daewoong Pharmaceutical Co. LTD.

Chief Medical Officer since 2022

MD from Seoul National University

Findings from Research

Pirfenidone and nintedanib have been shown to effectively prevent about 50% of the decline in lung function (forced vital capacity) in patients with idiopathic pulmonary fibrosis, making placebo-controlled trials ethically questionable for future studies.

The future management of idiopathic pulmonary fibrosis is likely to focus on combination therapies, as single-agent personalized medicine may not be practical due to the disease's complex nature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy: the future of management for idiopathic pulmonary fibrosis? Wuyts, WA., Antoniou, KM., Borensztajn, K., et al.[2022]

The IFIGENIA trial demonstrated that N-acetylcysteine, when used alongside prednisone and azathioprine, significantly slowed the decline in lung function in patients with idiopathic pulmonary fibrosis over 12 months.

Pirfenidone is the first approved antifibrotic drug for idiopathic pulmonary fibrosis in the EU, showing efficacy in slowing lung function decline and reducing disease progression in over 1,100 patients across four clinical trials, though it may cause side effects like gastrointestinal discomfort and skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of pulmonary fibrosis. New substances and new interventions]. Costabel, U., Bonella, F.[2021]

External controls (ECs) derived from historical randomized clinical trials (RCTs) showed comparable treatment effects to the original BMS-986020 trial for idiopathic pulmonary fibrosis (IPF), indicating their potential utility in enhancing trial efficiency.

In contrast, ECs from real-world data sources, such as registries and electronic health records, demonstrated a slower rate of lung function decline compared to the placebo group, suggesting they may not provide reliable comparability for evaluating new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources. Swaminathan, AC., Snyder, LD., Hong, H., et al.[2023]

In a Phase 2 study involving 253 patients with unclassifiable interstitial lung disease (uILD), pirfenidone demonstrated a significant improvement in forced vital capacity (FVC) compared to placebo over 24 weeks, regardless of whether patients had undergone surgical lung biopsy (SLB).

Patients with SLB showed a mean FVC change of -90.9 mL with pirfenidone versus -146.3 mL with placebo, while those without SLB had a mean change of 8.2 mL with pirfenidone versus -85.3 mL with placebo, indicating that pirfenidone may be effective across different patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Pirfenidone vs. Placebo in Unclassifiable Interstitial Lung Disease, by Surgical Lung Biopsy Status: Data From a post-hoc Analysis. Molina-Molina, M., Kreuter, M., Cottin, V., et al.[2022]

Bersiporocin, a new prolyl-tRNA synthetase inhibitor, was found to be safe and well-tolerated in a study involving 72 healthy adults, with no severe adverse events reported after doses up to 600 mg.

The drug demonstrated a significant reduction in pro-peptide of type 3 procollagen, indicating its potential antifibrotic effect, although no significant changes were observed in other biomarkers for idiopathic pulmonary fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerability, pharmacokinetic/pharmacodynamic characteristics of bersiporocin, a novel prolyl-tRNA synthetase inhibitor, in healthy subjects. Park, MY., Bae, S., Heo, JA., et al.[2023]

References

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

Combination therapy: the future of management for idiopathic pulmonary fibrosis? [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of pulmonary fibrosis. New substances and new interventions]. [2021]

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

External Control Arms in Idiopathic Pulmonary Fibrosis Using Clinical Trial and Real-World Data Sources. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Pirfenidone vs. Placebo in Unclassifiable Interstitial Lung Disease, by Surgical Lung Biopsy Status: Data From a post-hoc Analysis. [2022]

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

Safety, tolerability, pharmacokinetic/pharmacodynamic characteristics of bersiporocin, a novel prolyl-tRNA synthetase inhibitor, in healthy subjects. [2023]