Buloxibutid for Pulmonary Fibrosis

(ASPIRE Trial)

Recruiting at 161 trial locations

Overseen By Bernt Van Den Blink, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vicore Pharma AB

Must be taking: Licensed IPF therapy

Must not be taking: Pirfenidone

Disqualifiers: Malignancy, Airways obstruction, Liver disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called buloxibutid for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. The trial aims to evaluate the effectiveness and safety of the medicine, either alone or with other IPF treatments. Participants will receive either buloxibutid or a placebo (a non-active substance) for 52 weeks. Those who have had IPF for less than 7 years and are either on a stable IPF treatment or not on any treatment might be suitable candidates. For more details, visit www.aspire-ipf.com. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

If you are on a stable dose of licensed IPF therapy, you can continue taking it during the trial, except for pirfenidone, which is not allowed. If you are not currently on IPF treatment, any previous IPF therapy must have been stopped more than 8 weeks before joining the trial.

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

Research has shown that buloxibutid is safe and well-tolerated in previous studies. In a 36-week trial, mild-to-moderate hair loss was the main side effect, which resolved after discontinuing the treatment. No other major side effects were reported. These findings suggest that buloxibutid could be a promising option for people with idiopathic pulmonary fibrosis (IPF). ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for pulmonary fibrosis, like pirfenidone and nintedanib, work by slowing disease progression. But Buloxibutid is unique because it targets a different pathway that may directly impact lung tissue repair. Researchers are excited about Buloxibutid because it offers a new mechanism of action that could potentially improve lung function more effectively. With its novel approach and the possibility of better outcomes for patients, Buloxibutid stands out as a promising new option in the fight against this challenging condition.

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

Studies have shown that buloxibutid, an oral medication, can help people with idiopathic pulmonary fibrosis (IPF) breathe better. This medication activates a specific mechanism in the body that protects the lungs from damage. In a previous study, patients who took buloxibutid showed noticeable improvements in lung health over 36 weeks. These findings suggest that buloxibutid might slow lung damage in people with IPF. The trial will evaluate different dosages of buloxibutid, specifically 100 mg and 50 mg taken twice daily, compared to a placebo, over a 52-week period. This offers hope for those facing this challenging condition. ^{1 6 7 8 9}

Who Is on the Research Team?

Cecilia Ganslandt, MD

Principal Investigator

Vicore Pharma AB

Are You a Good Fit for This Trial?

This trial is for people with Idiopathic Pulmonary Fibrosis (IPF), a type of lung scarring. Participants can be on stable IPF therapy or not, but must meet certain health standards to join. Specific inclusion and exclusion criteria details are missing here, so check www.aspire-ipf.com for more info.

Inclusion Criteria

I was diagnosed with IPF within the last 5 years.

I have been on a stable dose of my IPF treatment for at least 8 weeks.

I am not currently on any approved treatment for IPF.

Exclusion Criteria

I have not had a lung infection needing antibiotics in the last 4 weeks.

I have liver problems or a significant liver disease.

I do not have any serious health conditions that could affect the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 6 weeks

Treatment

Participants receive either buloxibutid 100 mg BID, buloxibutid 50 mg BID, or placebo BID for 52 weeks

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Buloxibutid

Trial Overview

The ASPIRE trial tests the effectiveness and safety of Buloxibutid taken orally, compared to a placebo. It's designed as a double-blind study where neither participants nor researchers know who gets the real drug versus placebo over 52 weeks.

How Is the Trial Designed?

Group I: Buloxibutid 50 mg BID Experimental Treatment 1 Intervention

For 52 weeks.

Group II: Buloxibutid 100 mg BID Experimental Treatment 1 Intervention

For 52 weeks.

Group III: Placebo BID Placebo Group 1 Intervention

For 52 weeks.

Who Is Running the Clinical Trial?

Vicore Pharma AB

Lead Sponsor

Trials

11

Recruited

1,100+

Population Services International

Collaborator

Trials

25

Recruited

270,000+

Published Research Related to This Trial

In a study of 92 patients with idiopathic pulmonary fibrosis (IPF) receiving pirfenidone, the drug showed an acceptable safety profile, with skin-related (25%) and gastrointestinal (17.5%) adverse events being the most common, leading to discontinuation in 22.5% of cases.

Despite some patients experiencing significant improvements in lung function, the overall decline in lung function (%FVC and %DLCO) was noted over 36 months, highlighting the need for further research through prospective observational registries to better understand pirfenidone's long-term efficacy in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal "Real-World" Outcomes of Pirfenidone in Idiopathic Pulmonary Fibrosis in Greece. Tzouvelekis, A., Karampitsakos, T., Ntolios, P., et al.[2022]

In a study involving rats, halofuginone was found to significantly reduce pulmonary fibrosis caused by bleomycin, indicating its potential as a treatment option for this serious condition.

The treatment was administered every second day over a 42-day period, and the results showed a marked decrease in collagen levels in the lungs, highlighting halofuginone's effectiveness in inhibiting collagen type I synthesis associated with fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in pulmonary fibrosis in vivo by halofuginone. Nagler, A., Firman, N., Feferman, R., et al.[2012]

A series of novel derivatives of pirfenidone were designed and synthesized to find new treatments for pulmonary fibrosis, showing promising results in preliminary studies.

Most of these new compounds demonstrated significantly better anti-pulmonary fibrosis activity compared to the original drug, pirfenidone, indicating potential for improved therapeutic options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel pirfenidone derivatives: synthesis and biological evaluation. Yao, M., Sun, M., Chen, C., et al.[2023]

GDC-3280, an oral medication for idiopathic pulmonary fibrosis, was found to be generally well tolerated in a phase 1 trial with 80 participants, showing no serious adverse events and mostly mild side effects like headache and nausea.

The pharmacokinetics of GDC-3280 indicated that it is effectively absorbed, with significant increases in drug exposure when taken with food, supporting its future use in clinical trials for twice-daily administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized study to evaluate safety, tolerability, and pharmacokinetics of GDC-3280, a potential novel anti-fibrotic small molecule, in healthy subjects. Cheung, D., Fong, A., Ding, HT., et al.[2021]

Bleomycin is an effective agent for inducing pulmonary fibrosis in rodent models, which helps researchers study the disease mechanisms and test potential therapies.

The methods outlined for delivering bleomycin and measuring lung collagen content provide a standardized approach to quantify the severity of fibrosis, aiding in the evaluation of new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mouse models of bleomycin-induced pulmonary fibrosis. Walters, DM., Kleeberger, SR.[2016]

Citations

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clinicaltrials.gov/study/NCT06588686

NCT06588686 | A Trial to Evaluate Efficacy and Safety of ...

Buloxibutid is an oral angiotensin II type 2 (AT2) receptor agonist and has been shown to improve lung function in IPF over 36 weeks. Buloxibutid agonizes the ...

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trial.medpath.com/drug/60bce1ecfdfd6f2c/buloxibutid

Buloxibutid | MedPath

Vicore Pharma presented promising Phase 2a trial data at the 2025 ATS Conference showing buloxibutid significantly improved lung function in idiopathic ...

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vicorepharma.com/our-programs/rare-lung-diseases/c21-ipf-fibrosis/

Buloxibutid (C21) – IPF

The AIR trial is a phase 2a multi-center, open label, single arm 36-week trial evaluating the safety and efficacy of buloxibutid in patients with IPF. Read ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12171857/

A new era in the treatment of progressive fibrosing ...

Concerning patients with non-IPF progressive fibrosis, the INBUILD trial reported a slower decline in FVC over one year compared to placebo in ...

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synapse.patsnap.com

synapse.patsnap.com/drug/48153cede88447c19e63cef82a2f6cc1

Buloxibutid - Drug Targets, Indications, Patents

A randomized, double-blind, placebo-controlled, parallel-group, multicenter trial evaluating the efficacy and safety of 2 doses of Buloxibutid over 52 weeks.

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vicorepharma.com

vicorepharma.com/wp-content/uploads/2024/05/air-ats-2024.pdf

Buloxibutid (C21), a Novel Angiotensin II Type 2 Receptor ...

Buloxibutid was safe and well tolerated for the full 36-week duration of the trial. The only adverse effect identified was mild-to-moderate reversible hair ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10859786/

A study with buloxibutid, an angiotensin II type 2 receptor ...

Buloxibutid (100 mg per os, twice daily) is currently investigated in a phase II clinical study in patients with idiopathic pulmonary fibrosis ...

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trial.medpath.com

trial.medpath.com/clinical-trial/c020aa8b9926af77/nct06588686-efficacy-safety-buloxibutid-pulmonary-fibrosis

A Trial to Evaluate Efficacy and Safety of Buloxibutid in People ...

Buloxibutid is an oral angiotensin II type 2 (AT2) receptor agonist and has been shown to improve lung function in IPF over 36 weeks. Buloxibutid agonizes the ...

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sigma.larvol.com

sigma.larvol.com/product.php?e1=773211&tab=newstrac

buloxibutid (C21) News

Enrollment open: ASPIRE: A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis. (clinicaltrials.gov) - Oct 1, 2024