Buloxibutid for Pulmonary Fibrosis

(ASPIRE Trial)

Recruiting at 103 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Trial Summary

What is the purpose of this trial?

The ASPIRE trial is a 52 week randomized, double-blind, placebo-controlled, parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of orally administered buloxibutid, either on top of stable IPF therapy or as monotherapy, are assessed in participants with IPF. Trial website: www.aspire-ipf.com

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.

How is the drug Buloxibutid different from other treatments for pulmonary fibrosis?

Buloxibutid is unique because it is being studied specifically for its effects on pulmonary fibrosis, whereas existing treatments like pirfenidone have limitations in tolerability and effectiveness. Unlike some other treatments, Buloxibutid may offer a novel approach, potentially improving outcomes for patients with this condition. ^{1 2 3 4 5}

Research Team

Cecilia Ganslandt, MD

Principal Investigator

Vicore Pharma AB

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Buloxibutid (Other)

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Longitudinal "Real-World" Outcomes of Pirfenidone in Idiopathic Pulmonary Fibrosis in Greece. [2022]

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

Reduction in pulmonary fibrosis in vivo by halofuginone. [2012]

3. England pubmed.ncbi.nlm.nih.gov

Novel pirfenidone derivatives: synthesis and biological evaluation. [2023]

4. England 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. [2021]

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

Mouse models of bleomycin-induced pulmonary fibrosis. [2016]