INS018_055 for Idiopathic Pulmonary Fibrosis

No longer recruiting at 37 trial locations

Overseen By Weisheng Chen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: InSilico Medicine Hong Kong Limited

Must be taking: Antifibrotics

Disqualifiers: Acute IPF exacerbation, Smoking, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, INS018_055, for people with Idiopathic Pulmonary Fibrosis (IPF), a lung disease that makes breathing difficult. The researchers aim to determine if this treatment is safe and well-tolerated when taken orally for up to 12 weeks. Participants will receive either the new treatment or a placebo (a pill with no active medicine) to compare effects. Those diagnosed with IPF and having stable breathing conditions might be suitable for this study. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important advancements in IPF treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it allows participants who are already on stable doses of pirfenidone or nintedanib for more than 8 weeks to join. It seems you can continue these medications if they are stable.

Is there any evidence suggesting that INS018_055 is likely to be safe for humans?

Research has shown that INS018_055 has been promising in earlier studies. In preclinical tests conducted in labs or with animals, this drug produced positive results. Participants in earlier trials tolerated it well, with no major health issues reported.

Additionally, data from a previous study indicated that the drug was safe for humans, with only minor side effects. This is encouraging for prospective trial participants, as it suggests the treatment is likely safe based on earlier findings.

The trial aims to further assess safety and tolerance of the treatment over 12 weeks. ^{1 2 3 4 5}

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

Researchers are excited about INS018_055 for idiopathic pulmonary fibrosis because it offers a new approach compared to existing treatments like pirfenidone and nintedanib. Unlike these standard treatments, which primarily work by slowing disease progression, INS018_055 is believed to target the underlying disease mechanisms more directly, potentially improving lung function. This drug's unique dosing options, including once or twice daily regimens at different dosages, provide flexibility that could lead to better patient outcomes and adherence. Additionally, the potential for a meaningful impact on lung health within a 12-week period is a promising aspect that sets it apart from current options.

What evidence suggests that INS018_055 might be an effective treatment for Idiopathic Pulmonary Fibrosis?

Research shows that INS018_055 could be a promising treatment for idiopathic pulmonary fibrosis (IPF), a condition where lung tissue becomes thick and scarred. In earlier studies with mice, this molecule reduced the scarring. INS018_055 blocks TNIK, a protein linked to this scarring. Early results suggest that this drug might improve lung function in people with IPF. Initial tests have shown it to be safe. While more research is needed, these findings offer hope for those with IPF. Participants in this trial will receive either INS018_055 at varying doses or a placebo to further evaluate its effectiveness and safety. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults over 40 with Idiopathic Pulmonary Fibrosis (IPF) who meet specific lung function criteria can join this trial. They must have a stable condition and not have had an acute IPF exacerbation in the last 4 months. Smokers or those unwilling to quit, pregnant or nursing women are excluded.

Inclusion Criteria

I have been on a stable dose of pirfenidone or nintedanib for over 8 weeks.

I am 40 years old or older.

I have been diagnosed with IPF according to expert guidelines.

Exclusion Criteria

Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study

I have had a sudden worsening of my lung condition in the last 4 months.

Abnormal ECG findings

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INS018_055 or placebo orally for up to 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INS018_055

Trial Overview The study is testing INS018_055, taken orally for up to 12 weeks, against a placebo to see if it's safe and tolerable for adults with IPF. Some participants may also be on stable antifibrotic therapy like pirfenidone or nintedanib.

How Is the Trial Designed?

Group I: INS018_055 Experimental Treatment 1 Intervention

Group 1: INS018\_055 once daily up to 12 weeks, low dose Group 2: INS018\_055 twice daily up to 12 weeks, low dose Group 3: INS018\_055 once daily up to 12 weeks, high dose

Group II: Placebo Placebo Group 1 Intervention

Group 4: Placebo once or twice daily up to 12 weeks

INS018_055 is already approved in United States, China for the following indications:

Approved in United States as INS018_055 for:

• Idiopathic Pulmonary Fibrosis (IPF)

Approved in China as INS018_055 for:

• Idiopathic Pulmonary Fibrosis (IPF)

Who Is Running the Clinical Trial?

InSilico Medicine Hong Kong Limited

Lead Sponsor

Trials

9

Recruited

1,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05938920

NCT05938920 | Study Evaluating INS018_055 ... The primary objective is to evaluate the safety and tolerability of INS018_055 orally administered for up to 12 weeks in adult subjects with IPF compared to ...

2. insilico.com insilico.com/blog/first_phase2

First Generative AI Drug Begins Phase II Trials with Patients They chose the 55th molecule which showed promise in improving fibrosis and good safety profile in mouse models. Bringing efficiency to drug ...

3. pulmonaryfibrosis.org pulmonaryfibrosis.org/patients-caregivers/medical-and-support-resources/clinical-trials-education-center/pipeline/drug/idiopathic-pulmonary-fibrosis/ism001-055-(ins018_055)

INS018_055 Insilico Medicine Announces Positive Topline Results of ISM001-055 for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) Developed Using Generative AI. Learn ...

4. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A2904

INS018-055, A Novel Traf2- and NCK-interacting Kinase ... INS018-055, A Novel Traf2- and NCK-interacting Kinase (TNIK) Inhibitor, Improves Lung Function in Patients With Idiopathic Pulmonary Fibrosis: Results From a ...

5. nature.com nature.com/articles/s41587-024-02143-0

A small-molecule TNIK inhibitor targets fibrosis in ... Idiopathic pulmonary fibrosis (IPF) is an aggressive interstitial lung disease with a high mortality rate. Putative drug targets in IPF have ...