DWN12088 for Idiopathic Pulmonary Fibrosis

Recruiting at 41 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, DWN12088, for individuals with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that makes breathing difficult. The primary goal is to determine if DWN12088 is safe and effective compared to a placebo (a pill with no active medicine). The trial seeks participants who have been living with IPF and are either on stable medication or not currently taking any IPF drugs. It is suitable for those who have not experienced a recent flare-up of IPF and can manage daily life without worsening symptoms. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DWN12088 appears safe so far. In a study with 89 participants, researchers found no safety issues that would halt the trial. Most participants tolerated the treatment well, experiencing no major side effects.

Additionally, earlier patients using DWN12088 demonstrated its general safety, with few serious problems reported. These results suggest that DWN12088 could be a safe option for treating idiopathic pulmonary fibrosis, a lung disease with limited treatment options. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Idiopathic Pulmonary Fibrosis?

Unlike the standard treatments for Idiopathic Pulmonary Fibrosis (IPF), which often include antifibrotic drugs like pirfenidone and nintedanib, DWN12088 is unique because it functions as a PRS inhibitor. This new mechanism of action targets the disease in a different way by potentially interfering with the fibrotic process itself, which could lead to improved outcomes for patients. Researchers are excited about DWN12088 because it opens up a novel pathway for treatment, offering hope for better management of IPF symptoms and progression.

What evidence suggests that DWN12088 might be an effective treatment for Idiopathic Pulmonary Fibrosis?

Research has shown that DWN12088, also known as Bersiporocin, holds promise for treating Idiopathic Pulmonary Fibrosis (IPF). IPF is a lung disease that progressively worsens and makes breathing difficult. With current treatments limited, new options like DWN12088 are crucial. Early studies suggest this drug may slow the lung scarring process. Although researchers are still gathering more information on its effectiveness, the treatment has passed key safety tests, allowing further study. Participants in this trial will receive either DWN12088 or a placebo, suggesting that DWN12088 could become a new option for people with IPF. ^{1 2 3 4 6}

Who Is on the Research Team?

Song

Principal Investigator

AIDS Malignancy Consortium

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05389215

Study Details | NCT05389215 | Clinical Trial to Evaluate ... This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with Idiopathic Pulmonary ...

2. pulmonaryfibrosis.org pulmonaryfibrosis.org/patients-caregivers/medical-and-support-resources/clinical-trials-education-center/pipeline/drug/idiopathic-pulmonary-fibrosis/dwn12088

DWN12088 Study Purpose. This is randomized, double-blinded, placebo-controlled multicenter study to evaluate the safety and efficacy of DWN12088 in patients with ...

3. atsjournals.org atsjournals.org/doi/10.1164/ajrccm.2025.211.Abstracts.A1779

American Journal of Respiratory and Critical Care Medicine Background: Idiopathic Pulmonary Fibrosis (IPF) is a progressive lung disease with limited treatment options. Current therapies, such as pirfenidone and ...

4. rarediseaseadvisor.com rarediseaseadvisor.com/news/positive-safety-review-supports-phase2-trial-bersiporocin-ipf/

Safety Review Supports Phase 2 Trial of Bersiporocin in IPF Bersiporocin received a positive safety review from the third IDMC, which recommended continuation of the global phase 2 study in IPF.

5. biopharmaapac.com biopharmaapac.com/news/31/7086/daewoong-pharmaceuticals-bersiporocin-clears-third-idmc-safety-review-global-phase-2-ipf-trial-to-continue.html

Daewoong Pharmaceutical's Bersiporocin Clears Third ... The ongoing Phase 2 trial (ClinicalTrials.gov Identifier: NCT05389215) aims to evaluate the safety, tolerability, and efficacy of Bersiporocin ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10339703/

Safety, tolerability, pharmacokinetic/pharmacodynamic ... Tolerable safety, linear PK characteristic, and potential of collagen downregulation of bersiporocin justify further investigation of this agent ...