LYT-100 (Deupirfenidone) for Idiopathic Pulmonary Fibrosis

(ELEVATE Trial)

Recruiting at 134 trial locations

Overseen By Wassim Fares, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: PureTech

Disqualifiers: Obstructive airway, Connective tissue, Cardiovascular, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests LYT-100, a new drug, in adults aged 40+ with Idiopathic Pulmonary Fibrosis who haven't been treated before. It aims to see if the drug can slow down the decline in lung function.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients who have been on nintedanib for less than 6 months can participate, suggesting that some medications might be allowed.

What data supports the effectiveness of the drug LYT-100 for idiopathic pulmonary fibrosis?

LYT-100 is a modified version of pirfenidone, which has been shown in studies to slow down lung function decline and reduce disease progression in idiopathic pulmonary fibrosis. LYT-100 is designed to have a better safety profile while maintaining the effectiveness of pirfenidone. ^{1 2 3 4 5}

Is LYT-100 (Deupirfenidone) safe for humans?

LYT-100 (Deupirfenidone) has been tested in a phase 1 study and was well tolerated at doses up to 1000 mg twice daily, with only mild and temporary side effects. This suggests it may have a better safety profile compared to other similar drugs used for lung diseases. ^{1 3 4 5 6}

Research Team

Camilla Graham, MD

Principal Investigator

PureTech

Eligibility Criteria

This trial is for adults with Idiopathic Pulmonary Fibrosis (IPF) who are new to treatment or have had less than 6 months of a specific drug. They must be able to follow the study's procedures and not use tobacco products, including vaping. People with other lung diseases, recent serious heart issues, hospitalization due to COVID-19 or IPF flare-ups, or certain infections can't join.

Inclusion Criteria

I am willing and able to follow all study procedures.

I have IPF diagnosed by a doctor and haven't used nintedanib for more than 6 months.

Exclusion Criteria

I know the cause of my lung condition, such as radiation or an infection.

I was hospitalized for COVID-19 or a serious lung infection within the last 3 months.

I have a known cause for my lung condition, such as radiation treatment or an autoimmune disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LYT-100, pirfenidone, or placebo daily for up to 183 days

26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term extension

Participants may opt into continuation of treatment to evaluate tolerability and long-term safety

26 weeks

Treatment Details

Interventions

• LYT-100
• LYT-100 (Deupirfenidone)
• Pirfenidone
• Placebo

Trial Overview The study is testing LYT-100 against pirfenidone (an existing medication for IPF) and placebo in a randomized, double-blind setup where neither participants nor researchers know who gets which treatment until after the results are collected.

Participant Groups

Group I: LYT-100 825 mg TID Experimental Treatment 1 Intervention

LYT-100 (Deupirfenidone) 825 mg TID oral administration

Group II: LYT-100 550 mg TID Experimental Treatment 1 Intervention

LYT-100 (Deupirfenidone) 550 mg TID oral administration

Group III: pirfenidone 801 mg TID Active Control 1 Intervention

pirfenidone 801 mg TID oral administration

Group IV: Placebo Placebo Group 1 Intervention

Placebo oral administration

Who Is Running the Clinical Trial?

PureTech

Lead Sponsor

Trials

7

Recruited

830+

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]

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]

LYT-100 (deupirfenidone) was found to be well tolerated in a phase 1b study with 1000 mg doses administered twice daily, showing only mild and transient adverse events, which suggests a potentially safer profile compared to existing antifibrotic treatments.

The pharmacokinetic profile of LYT-100 demonstrated dose-proportionality and a higher ratio of the parent drug to its metabolite compared to pirfenidone, indicating that deuteration may positively influence its metabolism and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium-Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases. Chen, MC., Korth, CC., Harnett, MD., et al.[2022]

In a real-world study of patients with Idiopathic Pulmonary Fibrosis (IPF), both pirfenidone and nintedanib were found to have common side effects, primarily gastrointestinal, but these were manageable in most cases.

Despite treating older patients with more severe disease and additional health issues, the discontinuation rates due to side effects were similar to those observed in clinical trials, supporting the safety and efficacy of these treatments in broader patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real World Experiences: Pirfenidone and Nintedanib are Effective and Well Tolerated Treatments for Idiopathic Pulmonary Fibrosis. Hughes, G., Toellner, H., Morris, H., et al.[2020]

References

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

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

Antifibrotic Drug Use in Patients with Idiopathic Pulmonary Fibrosis. Data from the IPF-PRO Registry. [2021]

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

A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium-Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Real world experience on the effectiveness and safety of pirfenidone in patients with idiopathic pulmonary fibrosis in Taiwan. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Real World Experiences: Pirfenidone and Nintedanib are Effective and Well Tolerated Treatments for Idiopathic Pulmonary Fibrosis. [2020]